Hearing Research 430 (2023) 108709

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Hearing Research
journal homepage: www.elsevier.com/locate/heares

Effects of preloads on middle-ear transfer function and acoustic reflex

in ossiculoplasty with PORP
Merlin Schär∗, Ivo Dobrev, Christof Röösli, Alexander M. Huber, Jae Hoon Sim
Department of Otorhinolaryngology, Head & Neck Surgery, University Hospital Zurich, University of Zurich, Switzerland

a r t i c l e i n f o a b s t r a c t

Article history: Introduction: Surgical outcomes in ossiculoplasty with partial ossicular replacement prostheses (PORPs)
Received 1 August 2022 are greatly influenced by the amount of preload imposed on the PORP. In this study, the attenuation of
Revised 10 December 2022
the middle-ear transfer function (METF) was experimentally investigated for prosthesis-related preloads
Accepted 30 January 2023
in different directions, with and without concurrent application of stapedial muscle tension. Different
Available online 1 February 2023
PORP designs were assessed to determine functional benefits of specific design features under preload
Keywords: conditions.
Ossiculoplasty Methods: The experiments were performed on fresh-frozen human cadaveric temporal bones. The effect
Partial-ossicular replacement prosthesis of preloads along different directions were experimentally assessed by simulating anatomical variance
Preload and postoperative position changes in a controlled setup. The assessments were performed for three dif-
Annular ligament ferent PORP designs featuring either a fixed shaft or ball joint and a Bell-type or Clip-interface. Further,
Stapedial muscle
the combined effect of the preloads towards the medial direction with tensional forces of the stapedial
Acoustic reflex
muscle was assessed. The METF was obtained via laser-Doppler vibrometry for each measurement condi-
tion.
Results: The preloads as well as the stapedial muscle tension primarily attenuated the METF between 0.5
and 4 kHz. The largest attenuations resulted from the preload towards the medial direction. The attenua-
tion of the METF with stapedial muscle tension was reduced with concurrent PORP preloads. PORPs with
a ball joint resulted in reduced attenuation only for preloads along the long axis of the stapes footplate.
In contrast to the clip interface, the Bell-type interface was prone to lose coupling with the stapes head
for preloads in the medial direction.
Conclusions: The experimental study of the preload effects indicates a direction-dependent attenuation
of the METF, with the most pronounced effects resulting from preloads towards the medial direction.
Based on the obtained results, the ball joint offers tolerance for angular positioning while the clip in-
terface prevents PORP dislocations for preloads in lateral direction. At high preloads, the attenuation of
the METF with stapedial muscle tension is reduced, which should be considered for the interpretation of
postoperative acoustic reflex tests.
© 2023 Published by Elsevier B.V.

1. Introduction The ossiculoplasty with a partial ossicular replacement prosthe-

The functional integrity of the middle-ear ossicular chain can
be compromised by a variety of congenital and non-congenital
pathologies and damages of traumatic origin. The resultant con-
ductive hearing loss may be surgically treated by otologic proce-
dures which aim to rearrange or replace the affected middle-ear
structures. Ossiculoplasty is a common otologic procedure which
employs different types of implantable prostheses for the surgical
reconstruction of the middle-ear ossicular chain.
∗
Corresponding author.
E-mail address: merlin.schaer@usz.ch (M. Schär).
sis (PORP) establishes a linkage between the tympanic membrane
(TM) and the stapes head. While the ossiculoplasty with PORPs
may provide adequate closure of the air-bone gap in some patients,
the procedure suffers from variable outcomes with comparably low
success rates (Kamrava and Roehm, 2017). One of the major under-
lying causes is that the surgical outcome is highly sensitive even to
small changes of the prosthesis position and prosthesis length. The
position and length of the prosthesis affect the pretension of the
stapedial annular ligament (Neudert et al., 2016), which has been
shown to exhibit nonlinear stiffening properties under quasi-static
loads (Lauxmann et al., 2014). While excessive pretension causes
significant attenuation of the middle-ear sound transmission due
to the stiffening of the stapedial annular ligament, the lack of suf-

https://doi.org/10.1016/j.heares.2023.108709
0378-5955/© 2023 Published by Elsevier B.V.
M. Schär, I. Dobrev, C. Röösli et al.
Fig. 1. Schematic illustrations of the partial-ossicular replacement prostheses (PORPs) included in the experimental assessments: TTB (TTP- Tübingen Bell), CF (Clip Partial
FlexiBAL), and BF (Bell Partial FlexiBal), manufactured by Heinz Kurz GmbH (Dußlingen, Germany).
ficient pretension bears the risk of a postoperative prosthesis dislo-
cation. Unfortunately, prosthesis-related preloads on the stapedial
annular ligament are difficult to control objectively during middle-
ear surgery (Neudert et al., 2016).
Conventional PORPs share a common design blueprint con-
sisting of 1) a head plate interfacing with the TM and/or the
manubrium of the malleus, 2) an interface for coupling with the
stapes head, and 3) a shaft establishing a connection between the
headplate and the interface for the stapes head. To mitigate the
challenges which are commonly encountered in the ossiculoplasty
with PORPs, prosthesis designs with novel features have been de-
veloped. These new designs were created to 1) improve the tol-
erance of prosthesis length and angulation, thereby accounting for
high anatomical variance encountered across the patient popula-
tion, 2) improve intraoperative handling for the otologist, and 3)
increase robustness against postoperative position changes and po-
tential postoperative dislocation.
The first objective of this investigation was to experimentally
assess the functional roles of two novel design features which have
been added to the conventional PORP design, i.e., 1) a clip inter-
face for the stapes head (Hüttenbrink et al., 2004), and 2) a flexible
ball joint between the head plate and shaft (Beutner et al., 2011;
Gostian et al., 2013; Stoppe et al., 2018). The focus of the experi-
mental assessment was to determine how the novel features help
to retain functional outcomes despite the high anatomical variation
across different patients and the possibility of postoperative posi-
tion changes of the prosthesis. In the reconstructed ears, the pri-
mary purpose of the ossicular replacement prosthesis is to restore
middle-ear sound transmission akin to the sound transmission of
a normal middle ear. The experimental design of this investigation
was therefore based on the simulation of possible anatomical vari-
ance and postoperative position changes of the PORP. For each ex-
perimental condition, the middle-ear transfer function (METF), i.e.,
the ratio of the stapes velocity to the sound pressure level (SPL) in
the ear canal, was obtained. The measurements with the different
types of prostheses were performed in fresh-frozen human cadav-
eric temporal bones. The results of the measurements with the dif-
ferent prostheses were then compared to assess potential benefits
of the new design features.
The stapedial tendon may be preserved in the ossiculoplasty
with PORPs, thereby maintaining the functionality of the acous-
tic reflex in the reconstructed middle ears. The acoustic reflex is
assumed to provide an active protection mechanism for inner-ear
structures against high-intensity stimuli and/or enhancement of
speech discrimination in noisy environments (Djupesland, 1964;
Borg et al., 1984; Gelfand, 2017). The acoustic reflex is based on
a neural feedback loop, resulting in contractions of the stapedial
muscle in the presence of loud sound above a threshold of 70–
100 dB SPL via innervation by the facial nerve (Djupesland, 1964;
Laukli and Mair, 1980). The stapedial muscle is enclosed in a
bony canal which protrudes into a small tip, the pyramidal em-
inence. The stapedial tendon originates from the pyramidal emi-
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Hearing Research 430 (2023) 108709
nence and inserts at the posterior part of the stapes neck. Ten-
sional forces acting on the stapes neck via the stapedial tendon
upon contraction of the stapedial muscle are therefore approxi-
mately parallel to the long axis of the stapes footplate. The stape-
dial muscle tension increases the middle-ear impedance via stiff-
ening of the stapedial annular ligament, resulting in a reduction
of the middle-ear sound transmission. The contractile force of the
stapedial muscle becomes larger with increasing stimulus intensi-
ties (Kobrak, 1959), exhibiting fine-tuned contraction responses for
incremental changes of the stimulus intensity of down to 1 dB SPL
(Popelka and Hunter, 2013). The intensity of the eliciting stimu-
lus further affects the latency of the mechanical response, i.e., the
latency of the stapedial muscle contraction with subsequent stiff-
ening of the middle-ear ossicular chain. The latency is ∼100 ms
around the threshold of the acoustic reflex but may become as
small as 25 ms for higher-intensity stimuli (Yost, 20 0 0). While the
acoustic reflex in humans only involves the stapedial muscle, the
tensor tympani is part of the acoustic reflex in a variety of other
mammals (Gelfand, 2017).
The second objective of this study was to explore effects of
stapedial-muscle tension in correlation with different amounts of
preload between the stapes and the PORP and between the TM
and the PORP, which may be imposed intraoperatively and/or post-
operatively. These effects were investigated to identify potential
changes of acoustic reflex function via contractions of the stape-
dial muscle in the surgically reconstructed ears.
2. Materials and methods
2.1. Prostheses
Three different designs of PORPs were included in this investi-
gation, i.e., prostheses with 1) a Bell-interface to the stapes head
and a rigid connection between the head plate and the prosthesis
shaft (TTP-Tübingen Bell, Heinz Kurz GmbH, Dußlingen, Germany),
2) a Clip-interface with a ball joint between the head plate and the
prosthesis shaft (Clip Partial FlexiBAL, Heinz Kurz GmbH), and 3)
a Bell-interface with a ball joint between the head plate and the
prosthesis shaft (Bell Partial FlexiBal, Heinz Kurz GmbH) (Fig. 1).
The non-commercial ball-joint prosthesis with a Bell-interface (Bell
Partial FlexiBal) was manufactured by Heinz Kurz GmbhH for the
purpose of this study. The prostheses are hereafter referred to as
TTB (TTP- Tübingen Bell), CF (Clip Partial FlexiBAL), and BF (Bell
Partial FlexiBal).
2.2. Temporal bone preparation and surgical reconstruction
The investigation was performed on eight fresh-frozen human
cadaveric temporal bones (TBs) under the ethical approval by the
Ethic Committee of the Canton of Zurich (KEK-ZH-Nr. 2014–0544).
The specimens were acquired from Life Legacy Foundation (Tucson,
Arizona, USA) and Science Care (Phoenix, Arizona, USA). The TBs
M. Schär, I. Dobrev, C. Röösli et al.
Fig. 2. Experimental setup with the assembly of the artificial ear canal (AEC), artificial tympanic membrane (ATM), and PORP on a stack of three micro-stages.
were extracted within 72 h postmortem and subsequently stored
at a temperature of −20 °C in temperature-monitored freezers un-
til preparation.
The TB preparation involved a wide mastoidectomy and poste-
rior tympanotomy, followed by a visual inspection to detect ev-
ident pathological conditions of the middle-ear ossicular chain.
Subsequently, the vibrational motion of the stapes under acous-
tic stimulation was measured and the METF was calculated based
on the monitored sound pressure levels (SPL) in the artificial ear
canal (see Section 2.3 for more details). The results were checked
for compliance with the criteria for normal middle-ear behavior,
as established by the American Society for Testing and Materi-
als (American Society for Testing and Materials (ASTM) F2504-05,
2005). Only when the METF of the intact TBs complied with the
ASTM standard, the preparation of the specimen was continued,
by separating the intact TB into two parts: 1) An upper part con-
sisting of the ear canal, eardrum, malleus-incus complex, and sur-
rounding bone, and 2) a lower part with the intact stapes and
cochlea.
For the experimental assessments with stapedial muscle ten-
sion, the preparation involved additional steps to fully expose
the belly of the stapedial muscle. The top parts of the bony
canal harboring the belly of the stapedial muscle were carefully
removed using diamond burrs and micro-surgical tools. Subse-
quently, the tissue adhesions attaching the muscle belly to the
bony canal wall were meticulously detached along the full ex-
tent of the muscle, including the portions close to the pyramidal
process. Hüttenbrink (1988) proposed such a thorough removal of
soft-tissue adhesions to ensure an unimpeded load transfer to the
ossicles.
The lower part was mounted on an experimental bench setup,
and the short and long axes of the stapes footplate (SF) were
aligned with the X- and Y-axes of the reference frame of the micro-
stages (Fig. 2). A high-resolution camera providing a perpendicular
view onto the stapes footplate was used to visually assist the align-
ment.
For each prosthesis design and all preload conditions, the mea-
surements of the METF were performed within approximately
20 min. The samples were kept moist by using a humidifier and
by applying saline spray after each change of the preload condi-
tion. In case of suspected drying and after changing the prosthesis,
the sample was rehydrated in saline solution for at least 30 min
and the measurements were repeated, based on the results from a
previous study by our group (Gerig et al., 2015).
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Hearing Research 430 (2023) 108709
2.3. Measurement of middle-ear transfer function (METF) with
preloads on prosthesis
In place of the natural TM, powder-free exam gloves (KC300,
Kimberly-Clark, Irving, Texas, USA) were used to create artificial
tympanic membranes (ATMs). These ATMs were attached to a
small plastic tube with an inner diameter of 9 mm, which served
as an artificial ear canal (AEC). The assembly of the ATM and AEC
enabled efficient and precise control of preloads in four direc-
tions. Based on tympanometry measurements (ZODIAC 901, Mad-
sen Corp., USA), the compliance of the ATM was adjusted to yield
volume changes of 0.4–0.6 ml for a pressure of 2 kPa. These vol-
ume changes resemble values observed in normal-hearing patients.
The PORP was attached to the ATM by cyanoacrylate glue (Denseal
Superior, Prevest Denpro GmbH, Heidelberg, Germany), with the
prosthesis shaft aligned perpendicular to the ATM surface. Great
care was taken to apply small amounts of glue to avoid harden-
ing of the ATM or inadvertent fixation of the ball joint. An acoustic
chamber with a volume of 0.5 ml was created via insertion of a
yellow-foam ear-tip (ER1–14, Etymotic Research, Elk Grove Village,
Illinois, USA) into the AEC. To provide acoustic stimulation and
monitor the sound pressure levels in the AEC, probes of a loud-
speaker (ER-2, Etymotic Research) and a microphone (ER-7C, Ety-
motic Research) were introduced into the AEC through the yellow-
foam ear-tip.
The assembly consisting of the AEC, ATM, and the PORP was
subsequently mounted on a stack of three mutually orthogonal lin-
ear translation micro-stages. With this setup, the position of the
assembly could be precisely translated with micron-level accuracy
along three mutually orthogonal directions. The orientation of the
assembly was adjusted such that the longitudinal direction of the
PORP, i.e., the shaft of the prosthesis, was parallel to the Z-axis of
the reference frame of the micro-stages (as shown in Fig. 2).
Via the three translation micros-stages, the upper assembly
with the PORP was moved towards the stapes head, to establish
a connection with the PORP interface. A surgical microscope and
a high-resolution camera were used to assist in the positioning of
the upper assembly. After the upper assembly with the PORP was
moved into proximity of the stapes head, subsequent adjustments
via the micro-stages were performed in small motion increments
of 2 μm. While incrementally moving the assembly with the PORP
towards the stapes head, the stapes motion in response to acoustic
stimulation was measured via laser-Doppler vibrometry. The first
position which resulted in detectable stapes motion was used as
M. Schär, I. Dobrev, C. Röösli et al.
Fig. 3. Outline of the experimental protocol for the investigation of preload effects. Position changes of the artificial tympanic membrane (ATM) relative to the stapes
provided incremental amounts of preloads between the stapes and the PORP and between the ATM and the PORP. Preload effects were assessed for preloads applied along
the long axis of the stapes footplate, the short axis of the footplate, towards the lateral direction (i.e., away from the stapes footplate), and towards the medial direction (i.e.,
towards the stapes footplate).
an indicator for an established coupling between the stapes head
and the PORP without preload, thereby representing the baseline
position for the measurements.
The APx525 system (Audio Precision Inc., Beaverton, Oregon,
USA) was used for data acquisition and control of stimulation and
measurement parameters. For acoustic stimulation, harmonic sig-
nals in the range of 0.5–8 kHz were fed to the loudspeaker via an
audio amplifier (RMX 850a, QSC Audio Products, Costa Mesa, Cal-
ifornia, USA), with AEC sound pressure levels above 90 dB up to
8 kHz. The vibrational motion of the stapes was measured via a
laser Doppler vibrometry (LDV) system (OFV-3001, Polytec GmbH,
Waldbronn, Germany), which was mounted on a robot arm (KR16,
Kuka AG, Augsburg, Germany) with six degrees of freedom. The
laser beam of the LDV system was aimed near the center of the
stapes footplate by adjusting the position and orientation of the
robot arm accordingly. To establish a sufficiently high surface re-
flectivity for the laser beam of the LDV system, barium titanate
beads with retroreflective aluminum coating (∼50-μm diameter,
Cospheric LLC, Goleta, California, USA) were carefully placed on the
stapes footplate.
Different preload conditions were imposed by incrementally
changing the position of the upper assembly with the PORP rela-
tive to the stapes 1) along the long axis of the stapes footplate (to
the anterior direction), 2) along the short axis of the stapes foot-
plate (to the superior direction), 3) to the lateral direction (away
from the stapes footplate), and 4) to the medial direction (towards
the stapes footplate) (Fig. 3).
Starting from the baseline position, the position changes were
performed in increments of 50 or 100 μm. For each position of
the upper assembly and each prosthesis design, the measurements
were repeated 5 times and subsequently averaged. After acquiring
the sound pressure in the AEC and the velocity of the center of
the stapes footplate, the middle-ear transfer function (METF) was
calculated by
vSF
MET F = ,
PAEC
where vSF denotes the velocity of the stapes footplate center, and
PAEC the sound pressure in the AEC. While the exact angular posi-
tion of the laser beam in the measurement frame was not deter-
mined, it was held constant for all measurement positions of the
upper assembly (AEC, ATM, and PORP) and for all prosthesis de-
signs.
4
Hearing Research 430 (2023) 108709
2.4. Measurement of middle-ear transfer function (METF) with
stapedial muscle tension
The effect of stapedial muscle tension on the METF was only
assessed for the application of PORP preloads in the medial direc-
tion (i.e., towards the stapes footplate), which allowed for use of
the natural TM with the malleus instead of an ATM. As an addi-
tional change to the experimental protocol, only two PORPs of the
TTB type (see Fig. 1) were used for these measurements. As de-
scribed in Section 2.3, small quantities of cyanoacrylate glue were
used to attach the head plate of the PORP to the malleus handle,
under careful avoidance of glue reaching the natural TM.
To mimic stapedial muscle tension in the temporal bone spec-
imen, constant quasi-static forces were applied to the stape-
dial muscle via a 3-axis force sensor (PalpEar, Sensoptic, Losone,
Switzerland). The force sensor was connected to the stapedial
muscle via a custom-made interface based on a micro-pipette tip
(Fig. 4). To obtain the core component of the custom-made inter-
face, the narrow front region of a plastic micro-pipette tip was ex-
tracted. The shape of the removed segment resembled a frustum
of a cone with two different opening diameters. The belly of the
stapedial muscle was gently pushed into the larger opening, while
a surgical suture (4–0) was inserted into the smaller opening. Prior
to insertion of the thread and the muscle through the two aper-
tures, the tube had been filled with cyanoacrylate glue. After the
insertion of the muscle belly and the suture, UV-curable adhesive
(Blufixx GmbH, Wesseling, Germany) was additionally applied to
the region around the apertures to reinforce the attachment. The
3-axis force sensor was mounted on a motorized micro-stage for
precise control of the muscle-pulling forces. In the last step, the
free end of the surgical suture, which was maintained in a tension-
free state, was connected to the tip of the 3-axis force sensor with
UV-curable adhesive.
After determining the baseline position of the upper assembly
consisting of the AEC, TM, and PORP, increasing preloads were ap-
plied by incremental movements towards the medial direction (i.e.,
towards the stapes footplate). For each position of the PORP, the
measurements were first performed without muscle-pulling forces,
followed by measurements with application of constant muscle-
pulling forces with a magnitude of 10, 20, and 40 mN. The muscle-
pulling forces were applied towards the posterior direction, i.e., in
negative X-direction of the reference frame of the micro-stages,
parallel to the orientation of the stapedial tendon. For each of the
preload conditions, i.e., each position of the PORP, the magnitude
of the muscle-pulling force was continuously monitored and main-
tained within approximately ± 1 mN of the targeted force magni-
M. Schär, I. Dobrev, C. Röösli et al. Hearing Research 430 (2023) 108709

Fig. 4. Experimental setup for the mimicry of stapedial muscle tension. For each preload condition imposed on the prosthesis towards the medial direction (i.e., towards
the stapes footplate), different amounts of stapedial muscle-pulling forces were simulated via a 3-axis force sensor. Insert: Custom-made interface connecting the stapedial
muscle and the 3-axis force sensor via the extracted front segment of a micro-pipette tip.

Fig. 5. Middle-ear transfer functions (METFs) for preloads due to changes of the artificial tympanic membrane (ATM) position along the long axis of the stapes footplate
(towards the anterior direction) in TB1.

tude. A schematic representation of the measurement setup with
the mimicry of stapedial muscle tension and the micro-pipette in-
terface between the stapedial muscle and the 3-axis force sensor
is provided in Fig. 4.
3. Results
tion from measurements in n = 3 temporal bones are provided in
Fig. 8. Again, the overall trend was similar to the individual results
observed in TB1, and no clear difference between the three differ-
ent PORP designs was detected. Maximum attenuation levels did
not exceed ∼5 dB relative to the baseline position.

3.1. METFs with preloads on prosthesis

3.1.3. Movement of the TM to the lateral direction
The METFs with change of the ATM position to the lateral direc-
3.1.1. Movement of the TM along the long axis of the stapes footplate
tion (away from the stapes footplate) are outlined in Fig. 9, based
The effects on the METF resulting from the incremental changes
on data from TB1. With the TTB and BF prostheses, the coupling
of the ATM position along the long axis of the stapes footplate (to
between the PORP and the stapes head was lost for ATM position
the anterior direction) are shown in Fig. 5, based on data obtained
changes of 0.1 and 0.2 mm. In the results with the CF prosthesis,
in the sample TB1. In measurements with the TTB prosthesis, a 0.2-
there was no considerable change of the METF for any of the tested
mm movement of the ATM resulted in considerable attenuations of
ATM positions. The observation of a loss of coupling between the
the METF. In contrast, the results obtained for the CF and BF pros-
prosthesis and the stapes head with the TTB and BF prostheses
theses with a ball joint exhibited only minor attenuations. The av-
was consistent across samples for position changes of the ATM of
erage attenuation of the METF across measurements in n = 3 tem-
only 0.1 or 0.2 mm, which was reflected in the averaged data pre-
poral bones is provided in Fig. 6. The data in Fig. 6 shows the same
sented in Fig. 10. The CF prosthesis preserved a stable coupling to
trends as the results in Fig. 5, with attenuations of up to 12 dB rel-
the stapes head in the tested range of ATM positions, with peak
ative to the baseline position for a 0.2-mm movement of the upper
attenuations below 5 dB relative to the baseline position.
assembly with the TTB prosthesis.

3.1.2. Movement of the TM along the short axis of the stapes

footplate
The METFs with preloads imposed along the short axis of the
stapes footplate due to position changes to the superior direction
are illustrated in Fig. 7, based on data obtained in the sample TB1.
For all the PORP designs, the data indicated a gradual attenuation
of the METF with incremental movement of the ATM. However, no
major attenuation of the METF was found. The average attenua-
3.1.3.1. Movement of the TM to the medial direction. The METFs with
change of the ATM position to the medial direction (towards the
footplate, pushing the stapes into the cochlea) are presented in
Fig. 11, for individual measurements in TB1. For all tested PORP
designs, considerable attenuations of the METF were observed. The
averaged data follows this trend, with maximum average attenua-
tions of ∼9 dB (Fig. 12).

5
M. Schär, I. Dobrev, C. Röösli et al. Hearing Research 430 (2023) 108709

Fig. 6. Averaged attenuation of METFs (n = 3) for preloads due to changes of the artificial tympanic membrane (ATM) position along the long axis of the stapes footplate
(towards the anterior direction).

Fig. 7. Middle-ear transfer functions (METFs) for preloads due to changes of the artificial tympanic membrane (ATM) position along the short axis of the stapes footplate
(towards the superior direction) in TB1.

Fig. 8. Averaged attenuation of METFs (n = 3) for preloads due to changes of the artificial tympanic membrane (ATM) position along the short axis of the stapes footplate
(towards the superior direction).

3.2. METFs with preloads on prosthesis and stapedial muscle tension
Changes of the METF due to stapedial muscle tension at differ-
ent positions of the upper assembly (AEC, TM, and PORP) along the
latero-medial direction are presented in Fig. 13, for measurements
obtained in sample TB4. At the baseline condition without preload
(i.e., preload = 0), increasing force magnitudes of the stapedial
muscle tension resulted in larger attenuations of the METF. For
preloads induced by position changes of the upper assembly with
the PORP which were equal to or greater than 50 μm, no clear
attenuations of the METF by the stapedial muscle tension could
be observed. In comparison, while the muscle tension was able to
produce attenuations of up to ∼10 dB in the low-frequency range
without preload on the prosthesis, the maximal attenuation for the
0.2-mm position of the TM was smaller than 5 dB. The average
attenuations of the METF by stapedial muscle tension at differ-
ent preloads (i.e., TM position changes from baseline in the latero-
medial direction) are provided in Fig. 14. In these averaged results
from 5 measurements, attenuations of the METF with stapedial
muscle tension were present even for TM position changes above
50 μm. However, the averaged results followed a clear pattern
with reduced attenuations of the METF for larger position changes
of the TM.
4. Discussion and conclusion
4.1. Effects of preloads on middle-ear sound transmission
The surgical outcomes of the ossiculoplasty with PORPs are
substantially affected by the angular alignment of the PORP and
preloads between 1) the PORP and the stapes and 2) between
the PORP and the TM (Bance et al., 2004; Merchant et al., 1998;
Morris et al., 2004; Murugasu et al., 2005; Puria et al., 2005;
Yung and Vowler, 2006; Zhao et al., 2005). The angular position
of the PORP and the preloads are determined by several factors.
First, the middle-ear anatomy shows a large inter-individual vari-
ance across different patients. Ideally, the angle between the PORP
shaft and the stapes footplate as well as between the PORP shaft

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M. Schär, I. Dobrev, C. Röösli et al. Hearing Research 430 (2023) 108709

Fig. 9. Middle-ear transfer functions (METFs) for preloads due to changes of the artificial tympanic membrane (ATM) position to the lateral direction (away from the stapes
footplate) in TB1.

Fig. 10. Averaged attenuation of METFs (n = 3) for preloads due to changes of the artificial tympanic membrane (ATM) position to the lateral direction (away from the
stapes footplate).

Fig. 11. Middle-ear transfer functions (METFs) for preloads due to changes of the artificial tympanic membrane (ATM) position to the medial direction (towards the stapes
footplate) in TB1.

Fig. 12. Averaged attenuation of METFs (n = 3) for preloads due to changes of the artificial tympanic membrane (ATM) position to the medial direction (towards the stapes
footplate).

7
M. Schär, I. Dobrev, C. Röösli et al.
Fig. 13. Middle-ear transfer functions (METFs) for different pulling-forces of the stapedial muscle, with concurrent preloads imposed via position changes of the upper
assembly with the AEC, TM, and PORP along the latero-medial direction (towards the stapes footplate) in TB4.
and the TM would be 90° However, previous studies indicate that
the angle varies within a range of 60–90° (Beutner et al., 2011;
Gostian et al., 2013). Second, deviations from the optimal pros-
thesis length are detrimental to the surgical outcomes. Prostheses
which exceed the optimal length result in considerable preloads
and resultant pretension and stiffening of the stapedial annular lig-
ament, while prostheses which are shorter than the optimal length
increase the risk of postoperative prosthesis dislocations. Third, the
ultimate position of the prosthesis and the resulting preloads may
change postoperatively, even if the optimal prosthesis length was
selected during surgery. Underlying causes for these postoperative
changes include tissue growth, scar contraction, and TM move-
ments due to large variations of ambient static pressure (De Vos
et al., 2007; Gostian et al., 2013; Yung and Vowler, 2006). Prosthe-
ses with novel design characteristics have been developed to miti-
gate the potentially detrimental effect of these factors.
The clip interface to the stapes head was designed to en-
sure a secure connection of the PORP to the stapes head
(Hüttenbrink et al., 2004). The prosthesis is attached to the stapes
head such that the long legs of the clip are placed on the supe-
rior and inferior sides, and the short legs are placed on the ante-
8
Hearing Research 430 (2023) 108709
rior and posterior sides of the stapes (Fig. 15). This configuration
of the prosthesis legs is compatible with preservation of the stape-
dial tendon. Based on the results of the current study, the prosthe-
sis with the clip interface (CF) resulted in minor attenuations of
the METF when tensional preloads were applied on the PORP (i.e.,
when the upper assembly consisting of the AEC, ATM, and PORP
was moved away from the stapes in lateral direction). In striking
contrast, a complete loss of coupling to the stapes head was ob-
served for the PORPs with the Bell-type interface (TTB and BF) un-
der tensional preloads towards the lateral direction. Postoperative
changes may increase the required or optimal prosthesis length,
such that the length of the implanted prosthesis becomes too short
in the process. The obtained data indicates that under these cir-
cumstances, PORPs with the Bell-type interface (TTB and BF) bear
a high risk to lose coupling and to be rendered non-functional for
middle-ear sound transmission.
In efforts to mimic the flexibility of the human incudo-malleal
joint (IMJ) in reconstructed ears, the flexible ball joint between the
head plate and the prosthesis shaft was developed (Beutner et al.,
2011; Gostian et al., 2013; Stoppe et al., 2018). The functional role
of the flexible IMJ in the intact human middle ear has been in-
M. Schär, I. Dobrev, C. Röösli et al.
Fig. 14. Averaged attenuation of METFs (n = 5) for different pulling-forces of the stapedial muscle, with concurrent preloads imposed via position changes of the upper
assembly with the AEC, TM, and PORP along the latero-medial direction (towards the stapes footplate).
Fig. 15. Schematic illustration of the long and short legs of the clip interface fea-
tured in the CF prosthesis.
vestigated in previous studies. According to Willi et al. (2002), the
flexible IMJ results in a loss of sound-transmission energy at mid-
dle and high frequencies. Investigations of Gerig et al. (2015) indi-
9
Hearing Research 430 (2023) 108709
cated that the energy loss with a flexible IMJ reduces the piston-
like motion component of the stapes above 2 kHz. These observa-
tions on the functional implications of the flexible IMJ in humans
are distinct from the effects of the ball joint, which were evaluated
in the development phase of total-ossicular replacement prosthe-
ses (TORPs) and PORPs. These evaluations showed that the design
of the ball joint resulted in a low frictional energy loss through
the ball joint under acoustic stimulation (Beutner et al., 2011;
Gostian et al., 2013). In the intact human middle ear, the flexible
IMJ serves a protective role by decoupling the incus and the stapes
from large displacements of the TM and the malleus under static
pressure differences across the TM (Hüttenbrink, 1988, 1996; Ihrle
et al., 2013). Hüttenbrink (1988, 1996) and Warnholtz (2021) ob-
served that the flexible IMJ reduces inward movements of the
stapes under positive external pressure and outward movements
of the stapes under negative external pressure. The IMJ there-
fore establishes a protection mechanism with an immediate re-
sponse against large ambient static pressure changes. Further-
more, the flexibility of the IMJ influences the dynamic motion
of the middle-ear ossicular chain in response to acoustic stimuli.
M. Schär, I. Dobrev, C. Röösli et al.
Warnholtz et al. (2021) demonstrated that a decreased mobility
of the IMJ increases the attenuation of vibrational motion under
static pressure loads. Based on this observation, the flexible IMJ
may serve as an adaptation mechanism for improved hearing un-
der ambient static pressure variations. The results of the current
study indicate that the effects of the preloads are dependent on
the application direction of the preload. Compared to the prosthe-
sis without the ball joint (TTB), the attenuation of the METF in
measurements with the ball-joint prostheses (BF and CF) was only
reduced for the preloads along the long axis of the stapes footplate.
No substantial differences in the attenuation of the METF could
be observed between the PORPs with or without a ball joint for
the preloads along the short of the stapes footplate as well as for
the compressive preloads (i.e., when the ATM was moved towards
the stapes footplate). In the intact middle ear, similar attenua-
tions for both negative and positive static pressure loads have been
reported in the literature (Homma et al., 2010; Murakami et al.,
1997; Warnholtz et al., 2021). In the current study, measurements
with the prosthesis featuring the clip interface (CF) revealed larger
attenuations for the tensional preloads than for the compressive
preloads. These findings challenge the notion that the ball joint in
the PORP mimics the physiologic behavior of the flexible IMJ. More
accurately, the functional role of the ball joint is to provide adjust-
ments of the angle variation between the headplate and the shaft
of the PORP. Such variations may occur due to anatomical differ-
ences between patients and/or various postoperative changes.
The following conclusions may be drawn from the experimental
results obtained in this study. First, the flexible ball joint increases
the tolerance for the angular positioning of the prosthesis. Second,
the clip interface for the stapes head ensures a stable coupling be-
tween the prosthesis and the stapes head under tensional forces
between the PORP and the stapes head. Such tensional forces be-
tween the PORP and the stapes and between the PORP and the TM
may occur in the case that the intraoperatively employed prosthe-
sis length is below the required length or if the required length
increases postoperatively. Third, the effect of the preloads on the
METF depends on the directionality of the preload. In compari-
son, compressive forces (i.e., preload towards the medial direction)
between the prosthesis and the stapes and between the prosthe-
sis and the TM were larger than the attenuations resulting from
preloads which were imposed in other directions. The difference in
the attenuation of the METF depending on the direction of preload
can be explained by considering 1) the specific geometry and re-
sultant inhomogeneous stiffness distribution of the stapedial annu-
lar ligament and 2) the progressive stiffening characteristics of the
stapedial annular ligament (e.g., see Lauxmann et al., 2014). Based
on the study of Lauxmann et al. (2014), the stiffness at a given
working point as well as the progressive stiffening of the stapedial
annular ligament vary depending on the displacement direction of
the stapes. The observations of this study, such as 1) different at-
tenuations of the METF depending on the preload direction and
2) largest attenuations for the preloads in the lateral direction are
consistent with the findings of Lauxmann et al. (2014).
Otologists commonly apply moderate compressive preloads dur-
ing surgery, to reduce the risk of postoperative dislocations of the
prosthesis and to ensure reliable coupling between the TM and the
head plate as well as between the coupler and the stapes head.
Determining the optimal amount of preload is a delicate balancing
act, since only small excessive amounts of compressive preloads
may result in considerable attenuations of the METF in the recon-
structed ears (Neudert et al., 2016).
The results presented in Section 3.2 of this study were obtained
with an ATM. The flat shape of the ATM limits a direct translation
of the METFs to the clinical situation due to the conical shape of
the natural human TM. The mechanical properties and behavior of
the ATM are not identical to the mechanical properties and me-
10
Hearing Research 430 (2023) 108709
chanical behavior of the natural human TM, even though the ATM
compliance was adjusted to yield volume changes of 0.4–0.6 ml
for a pressure of 2 kPa. However, the relative attenuation of the
METF with preloads is presumed to be largely due to the stiffen-
ing of the stapedial annular ligament because previous studies re-
vealed that the stiffening of the natural TM is negligible compared
to the stiffening of the stapedial annular ligament for the range
of preloads applied in this study (e.g., see Neudert et al., 2016). In
Neudert et al. (2016), elongations of an expandable total ossicu-
lar replacement prosthesis of up to 300 μm relative to the optimal
prosthesis length resulted in no distinct stiffening of the natural
TM in the reconstructed middle ear. In contrast, even prosthesis
elongations of 50 μm relative to the optimal prosthesis length re-
sulted in considerable stiffening of the stapedial annular ligament
and subsequent attenuation of the METF. Similar to the natural TM,
the ATM used in this study does not exhibit significant stiffening
in the applied range of preloads. Therefore, we presume that the
ATM does not represent a substantial limitation for the purpose of
this investigation.
4.2. Acoustic reflex with preloads on prosthesis
The mechanical effects resulting from the contraction of the
middle-ear muscles on the static and dynamic middle-ear ossic-
ular motion have been subject to previous experimental investi-
gations. Dahmann (1929) conducted experimental investigations of
the stiffening of the middle-ear due to contractions of the middle-
ear muscles, showing that the application of strain on the middle-
ear muscles reduces the displacements of the ossicles. Hüttenbrink
(1988; 1989) developed an experimental setup for the measure-
ment of static displacements of the middle-ear ossicles under
static pressure loads and pulling-forces of the middle-ear muscles.
The reported approach for mimicry of muscular contraction was
based on the application of pulley-connected weights to the bellies
of the tensor tympani and the stapedial muscle. For the stapedial
muscle, a weight of 5 g was attached in one of the experimen-
tal studies (Hüttenbrink, 1988), while varying weights between 1
and 20 g were used in another investigation (Hüttenbrink, 1989).
Pau et al. (2005) and Bance et al. (2013) applied a similar approach
based on weights on a pulley system to mimic the effects of mus-
cular contraction, but the investigations solely focused on the ten-
sor tympani.
In the current study, it was possible to employ a more compact
setup for the mimicry of stapedial muscle tension by employing a
3-axis force sensor. The forces which were applied on the stape-
dial muscle were monitored and maintained via feedback control
within approximately ± 1 mN of the designated force magnitude.
To avoid excessive strains on the stapedial annular ligament, the
magnitude of the tensional forces was limited to a maximum of
40 mN (which corresponds to a weight of 4.08 g). The maximum
force magnitude resulted in an attenuation of the METF in the sur-
gically reconstructed ears with the PORP of around 10 dB (rela-
tive to the METF without muscle tension) in the frequency range
of 0.8–2.5 kHz (first graph in Fig. 14). The attenuation effect de-
creased at higher frequencies.
The stiffening of the middle ear due to stapedial muscle ten-
sion under high-intensity acoustic stimuli is utilized for diagnostic
purposes in the clinical setting. The acoustic reflex depends on the
condition of the hearing pathway through the middle and inner
ears, the signal transmission via the 7th and 8th cranial nerves
(CNVs), and the brainstem. In tympanometry, the condition of
this pathway can be checked by measuring middle-ear impedance
changes resulting from the contraction of the stapedial muscle. The
tests are performed with acoustic stimuli of 0.5, 1, 2, and 4 kHz.
The acoustic reflex test includes the measurements of the acoustic
reflex threshold (ART), defined as the minimal sound pressure level
M. Schär, I. Dobrev, C. Röösli et al.
(SPL) to elicit a mechanical response, i.e., a change in the middle-
ear impedance due to contraction of the stapedial muscle. The ART
is determined for both ears and commonly within the range of
70–100 dB SPL in normal-hearing subjects (Laukli and Mair, 1980).
Considering the results presented in Fig. 14, the attenuation of the
middle-ear sound transmission due to stapedial-muscle tension in
the frequency range of 0.5–4 kHz is still evident in the recon-
structed ears with the PORP. This observation indicates that the
acoustic reflex test retains its validity even for measurements after
surgical reconstruction, if the preloads are sufficiently small. How-
ever, considering the results provided in the last graph of Fig. 14,
acoustic reflex tests may not detect changes of the middle-ear
impedance upon contraction of the stapedial muscle if the preloads
are excessively high. The tensional forces of the stapedial muscle
stiffen the stapedial annular ligament, which results in an increase
of the middle-ear impedance (Rosowski, 2013). The application of
large preloads on the prosthesis in the reconstructed middle ears
already results in considerable stiffening of the stapedial annular
ligament. In this case, the tensional forces of the stapedial muscle
may not be sufficient to contribute to additional stiffening of the
stapedial annular ligament and may therefore not produce further
attenuation of the middle-ear sound transmission. These aspects
should be considered for the interpretation of the acoustic reflex
test after ossiculoplasty.
Remarks: This research article is based on a thesis chapter of:
Schär, M.W. (2022). Protective and Adaptive Functions of the Human
Middle Ear: Roles of the Stapedial Annular Ligament and the Stape-
dial Muscle (PhD thesis, Faculty of Science, University of Zurich,
Switzerland).
Conflicts of Interest
No conflict of interest to declare.
CRediT authorship contribution statement
Merlin Schär: Conceptualization, Methodology, Software, Inves-
tigation, Formal analysis, Visualization, Writing – original draft,
Writing – review & editing. Ivo Dobrev: Methodology, Investi-
gation. Christof Röösli: Methodology, Investigation. Alexander M.
Huber: Conceptualization, Supervision, Project administration,
Funding acquisition. Jae Hoon Sim: Conceptualization, Methodol-
ogy, Investigation, Formal analysis, Writing – original draft, Writing
– review & editing, Supervision, Project administration.
Data availability
Data will be made available on request.
Acknowledgments
We would like to acknowledge the help from Dr. Daiki Tak-
agi (Department of Otolaryngology, Head & Neck Surgery, Ehime
University Hospital, Toon, Japan) and Dr. Mansour Alshamani (De-
partment of Otolaryngology, Head & Neck Surgery, Ohud Hospital,
Medina, Saudi Arabia) who contributed to a part of the experi-
mental work. Further, we would like to thank Heinz Kurz GmbH
(Dußlingen, Germany) for providing the prostheses used in this
study.
This work was supported by the SNSF (Swiss National Science
Foundation) Grant No. No. 320030-176123.
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