Original Research—Otology and Neurotology
Otolaryngology–
Long-term Outcomes of Titanium
Ossiculoplasty in Chronic Otitis Media
Brendan P. O’Connell, MD1, Habib G. Rizk, MD2,
Tanisha Hutchinson, MD2, Shaun A. Nguyen, MD2, and
Paul R. Lambert, MD2
Sponsorships or competing interests that may be relevant to content are dis-
closed at the end of this article.
Abstract
Objective. The primary objective is to report long-term hear-
ing outcomes (.2 years) after titanium ossiculoplasty in
patients with chronic otitis media.
Study Design. Case series with chart review.
Setting. Tertiary care hospital.
Subjects and Methods. In total, 156 patients with chronic otitis
media undergoing titanium ossiculoplasty were included. The pri-
mary outcome measure was the long-term postoperative ABG.
The stability of hearing over time was determined by comparing
short-term and long-term postoperative air-bone gap (ABG).
Secondary outcome measures included DABG, postoperative
speech reception thresholds, air-conduction pure-tone average (AC
PTA), word recognition scores, and percentage of patients achieving
ABG 20 dB. Revision and extrusion rates were examined.
Results. At short-term follow-up (\6 months), mean post-
operative ABG was 18.4 6 10.6 dB and AC PTA was 31.7 6
15.2 dB; 67% of patients achieved ABG 20 dB. At long-term
follow-up (.2 years), mean ABG was 20.0 dB 6 15.4 and AC
PTA was 35.3 6 16.1 dB; 60% of patients achieved ABG 20.
At both short- and long-term follow-up, ABG and AC PTA
were significantly improved compared with preoperative
values. No difference in hearing outcomes was observed when
comparing partial titanium ossicular prostheses (PORPs) to
total titanium ossicular prostheses (TORPs) at either short-
or long-term follow-ups. In patients with both short- and long-
term follow-up (n = 50), deterioration in hearing was noted
(3.4 dB, P = .04). When analyzed by type of prosthesis, PORPs
demonstrated statistically significant deterioration in ABG over
time (4.9 dB, P = .02), while TORPs did not (2.5 dB, P = .50).
The long-term extrusion rate was 3.2%.
Conclusion. With a minimum follow-up of 2 years, titanium
ossiculoplasty provides good long-term hearing results.
Modest deterioration in hearing is noted over time.
Keywords
titanium, ossicular chain reconstruction, ossiculoplasty,
chronic ear disease, chronic otitis media
Head and Neck Surgery
2016, Vol. 154(6) 1084–1092
Ó American Academy of
Otolaryngology—Head and Neck
Surgery Foundation 2016
Reprints and permission:
sagepub.com/journalsPermissions.nav
DOI: 10.1177/0194599816633669
http://otojournal.org
Received June 18, 2015; revised January 19, 2016; accepted January 29,
2016.
S
ince the advent of ossiculoplasty in the 1950s, a wide
variety of materials have been used for ossicular chain
reconstruction (OCR). Titanium ossicular implants
were introduced in the 1990s, and their use is now wide-
spread. Proponents of titanium implants credit the material’s
light weight, rigidness, and low impedance for its favorable
acoustic characteristics. Furthermore, the small size of tita-
nium prostheses and open head design enhances surgeon
visualization and facilitates placement.
Most of the data regarding the success of titanium ossicu-
loplasty pertain to short-term hearing outcomes. In general,
early hearing results demonstrate reasonable closure of the
air-bone gap (ABG) with a low prosthesis extrusion rate.1-8
Long-term outcomes of titanium ossiculoplasty, particularly
in patients with chronic ear disease, are less clear. Such data
are essential, as disease-specific factors related to chronic
otitis media may predispose to deterioration in hearing over
time in this population.9 Residual cholesteatoma and seque-
lae of persistent eustachian tube disease can take years to
clinically manifest and may not be apparent in the early
postoperative period.
Therefore, the principal aim of this article is to report
long-term outcomes (.2 years) after titanium ossiculoplasty
by the same surgeon in patients with chronic otitis media.
The long-term stability of titanium prostheses will also be
determined by comparing findings at short- and long-term
follow-up. We hypothesize that (1) long-term hearing results
and complication profiles will be favorable, and (2) only
modest deterioration in hearing will be observed with time.
1
Department of Otolaryngology, Vanderbilt University, Nashville,
Tennessee, USA
2
Department of Otolaryngology–Head and Neck Surgery, Medical
University of South Carolina, Charleston, South Carolina, USA
This article was presented at the 2015 AAO-HNSF Annual Meeting and
OTO EXPO; September 27-30, 2015; Dallas, Texas.
Corresponding Author:
Brendan P. O’Connell MD, Department of Otolaryngology, Vanderbilt
University, 1215 21st Ave S, Nashville, TN 37232, USA.
Email: brendanoconnel@gmail.com
O’Connell et al
Methods
Patient Selection
Patients undergoing ossiculoplasty by the senior author
(P.R.L.) between August 2002 and December 2013 were
enrolled in a prospective database. Inclusion criteria were
chronic otitis media, with or without cholesteatoma, and
placement of a partial titanium ossicular prosthesis (PORP)
or total titanium ossicular prosthesis (TORP). In patients
requiring revision surgery, only the first ossiculoplasty oper-
ation performed by the senior author was included to elimi-
nate bias. Patients, however, who had prior ossiculoplasty
elsewhere and underwent revision surgery with the senior
author were included. Baseline demographic and clinical
characteristics, including patient sex, age at surgery, chronic
otitis media with cholesteatoma vs chronic otitis media with-
out cholesteatoma, presence of a malleus, staged vs unstaged
procedure, and prior mastoid surgery were recorded. The
study was approved by the Medical University of South
Carolina Institutional Review Board.
Audiometric Methods
Short-term results were analyzed using initial postoperative
audiograms routinely obtained within 6 months after sur-
gery. Long-term hearing outcomes were assessed with the
most recent audiogram obtained at least 2 years after OCR.
Preoperative and postoperative audiometric data were recorded
according to the American Academy of Otolaryngology—Head
and Neck Surgery (AAO-HNS) standards for reporting.10 Air-
conduction (AC) and bone-conduction (BC) thresholds at 0.5, 1,
2, and 3 kHz were recorded and used to calculate pure-tone
averages (PTAs). If the 3-kHz threshold was not recorded,
the average of the 2- and 4-kHz thresholds was used.11
The ABG was calculated as AC PTA minus BC PTA. The
ABG closure (DABG) was calculated as preoperative ABG
minus postoperative ABG. Preoperative and postoperative
speech reception thresholds (SRTs) were recorded. If
patients had incomplete pure-tone thresholds but an SRT
was documented, ABG data were not calculated but the
SRT was included for analysis. Vice versa, if ABG data
could be calculated but no SRT was documented, the data
were included in the ABG analysis. Postoperative BC PTA
was used as a measure of cochlear function to determine
whether a postoperative increase in PTA was due to a con-
ductive or sensorineural hearing loss.
Outcome Measures
The primary outcome measure of interest was the long-term
postoperative ABG. The stability of hearing over time was
determined by comparing short-term and long-term post-
operative ABG. Secondary outcome measures included
DABG, postoperative SRTs, AC PTA, word recognition
scores (WRS), and percentage of cases achieving an ABG
20 dB. Attaining an ABG 20 dB is a frequently cited
measure of success in ossiculoplasty; larger unilateral con-
ductive losses with a normal contralateral ear result in sig-
nificant asymmetry, limiting the benefits conferred by
1085
binaural hearing. Scattergrams were constructed according
to the recent AAO-HNS standardized format for reporting
hearing outcomes.12 The rates of extrusion and revision sur-
gery were also assessed.
Surgical Methods
The extent of surgery is determined by the severity of pathol-
ogy and clinical history. Our operative approach and tech-
niques have previously been reported.6 The prosthesis is
sized so that it just meets the tympanic membrane. Cartilage
is interposed between the head of the titanium prosthesis and
the tympanic membrane. Cartilage is harvested from the con-
chal bowl and cut to approximately a 0.5-mm thickness using
a Kurz (Kurz GmbH, DuBlingen, Germany) cartilage cutter.
Antibiotic-soaked gelfoam is placed in the middle ear to sta-
bilize the prosthesis. When the handle of the malleus is pres-
ent, the head of the prosthesis is usually positioned posterior
to it. In cases where the manubrium is posteriorly located
near the stapes/oval window area, the prosthesis is placed
such that it contacts the malleus.
Statistical Analysis
Data were analyzed using GraphPad Prism 6.0 software
(GraphPad Software, La Jolla, California), Sample Power 2.0
(IBM SPSS, Armonk, New York), and SigmaPlot 12.5
(Systat Software, Chicago, Illinois). Continuous variables
were tested for normal distribution as determined by the
D’Agostino and Pearson omnibus normality test. Comparisons
of categorical variables were performed using a Fisher’s exact
test or x 2 test. For continuous variables, comparisons between
groups (PORP vs TORP) were made with an independent t
test (normal distribution) or a Mann-Whitney U test (nonnor-
mal distribution). Paired t test or Wilcoxon signed rank test
was used to measure stability in ABG from short- to long-term
follow-up. In addition, a t test for 2 independent samples of
common variance was performed (PORP vs TORP) for post-
operative ABG based on a 2-tailed and a level of 0.05. A
value of P \ .05 was considered indicative of statistical
significance.
Results
Subjects
A total of 174 consecutive titanium OCRs were performed
in patients with chronic otitis media between August 2002
and December 2013. Eighteen patients lacked follow-up
prior to 6 months or after 2 years and were excluded. This
resulted in 156 patients for analysis. Of these, 149 patients
had short-term (\6 months) audiometric follow-up, 64
patients had long-term (.2 years) audiometric follow-up,
and 50 patients had both.
Baseline characteristics of patients with short-term follow-
up are summarized in Table 1. Comparison of preoperative
audiometric data revealed that patients reconstructed with
PORPs had a lower mean preoperative ABG, SRT, and AC
PTA compared with those with TORPs (P = .004, 0.04, and
0.004, respectively). Preoperative PTA and WRS are also
1086 Otolaryngology–Head and Neck Surgery 154(6)

Table 1. Preoperative Demographic and Audiometric Data for All Patients with Short-Term Follow-up.a
Overall (n = 149) PORP (n = 56) TORP (n = 93) P Value

Sex
Male 79 (53.0) 28 (50.0) 51 (54.8) .68
Female 70 (47.0) 28 (50.0) 42 (45.2)
Age at surgery, mean 6 SD, y 30.1 6 19.6 32.2 6 19.6 28.8 6 20.1 .20
Diagnosis
COM without cholesteatoma 69 (46.3) 25 (44.6) 44 (47.3) .88
COM with cholesteatoma 80 (53.7) 31 (55.4) 49 (52.7)
Presence of malleus 87 (58.4) 35 (62.5) 52 (55.9) .54
Staged ossiculoplasty 77 (51.7) 31 (55.4) 46 (49.5) .60
Prior mastoidectomy
ICW 63 (42.3) 25 (44.6) 38 (40.9) .78
CWD 20 (13.4) 7 (12.5) 13 (14.0) .99
Preoperative ABG
n 146 54 92 .004
dB, mean 6 SD 35.3 6 13.3 30.9 6 13.3 37.9 6 12.6
Range dB (minimum-maximum) 11.9-73.8 12.5-63.8 11.9-73.8
Preoperative SRT
n 141 52 89 .04
dB, mean 6 SD 43.8 6 14.7 40.7 6 16.1 45.6 6 13.5
Range dB (minimum-maximum) 15.0-95.0 15.0-95.0 15.0-85.0
Preoperative AC PTA
n 148 55 93 .004
dB, mean 6 SD 51.3 6 15.4 47.3 6 17.5 53.8 6 13.6
Range dB (minimum-maximum) 20.6-104.4 20.6-104.4 28.1-95.0

Abbreviations: ABG, air-bone gap; AC, air conduction; COM, chronic otitis media; CWD, canal wall down; ICW, intact canal wall; PORP, partial titanium ossi-
cular prosthesis; PTA, pure-tone average; SRT, speech reception threshold; TORP, total titanium ossicular prosthesis.
a
Values are presented as number (%) unless otherwise indicated.

presented in Figure 1. Kurz prostheses were used in 93.9%

(140/149) of cases.
Demographics and clinical characteristics of the 64 patients
with long-term follow-up are depicted in Table 2. PORPs
again had a lower mean preoperative ABG, SRT, and AC
PTA compared with the TORPs. Preoperative PTA and WRS
for patients with long-term follow-up are presented in Figure
2. Kurz prostheses were used in 90.6% (58/64) of cases.

Short-Term Audiometric Outcomes

The mean time to short-term follow-up was 3.2 6 1.4
months. Short-term hearing outcomes are reported in Table
3. No differences were noted between PORP and TORP
groups with regard to audiometric outcomes. The power of
the performed test for the primary outcome measure of inter-
est, short-term postoperative ABG, was 0.413 and below the
desired power of 0.800. Figure 1. Preoperative air-conduction pure-tone average and
The mean postoperative ABG at \6 months (18.4 6 10.6 word recognition scores in patients with short-term follow-up.
dB) was significantly lower than the preoperative ABG (35.3
6 13.3 dB) (P \ .0001). Similarly, mean short-term SRT
(25.9 6 15.4 dB) was significantly improved compared with dB) was significantly better than preoperative AC PTA (51.3
preoperative SRT (43.8 6 14.7 dB) (P \ .0001). Short-term 6 15.4 dB) (P \ .0001). No change in WRS was noted
changes in AC PTA and WRS after ossiculoplasty are pre- between preoperative (96.2% 6 7.5%) and short-term post-
sented in Figure 3. Mean short-term AC PTA (31.7 6 15.2 operative follow-up (96.4% 6 7.2%) (P = .79).
O’Connell et al 1087

Table 2. Preoperative Demographic and Audiometric Data for All Patients with Long-Term Follow-up.a
Overall (n = 64) PORP (n = 29) TORP (n = 35) P Value

Sex
Male 28 (43.8) 13 (44.8) 15 (42.9) .87
Female 36 (56.3) 16 (55.2) 20 (57.1)
Age at surgery, mean 6 SD, y 29.1 6 19.6 29.0 6 17.9 29.2 6 21.3 .93
Diagnosis
COM without cholesteatoma 26 (40.6) 9 (31.0) 17 (48.6) .24
COM with cholesteatoma 38 (59.4) 20 (69.0) 18 (51.4)
Presence of malleus 35 (54.7) 16 (55.2) 19 (54.3) .94
Staged ossiculoplasty 37 (57.8) 20 (69.0) 17 (48.6) .16
Prior mastoidectomy
ICW 31 (48.4) 17 (58.6) 14 (40.0) .23
CWD 8 (12.5) 1 (3.4) 7 (20.0) .06
Preoperative ABG
n 62 28 34 .0008
dB, mean 6 SD 33.4 6 12.9 28.2 6 12.5 37.7 6 11.7
Range dB (minimum-maximum) 12.5-63.8 12.5-63.1 14.4-63.8
Preoperative SRT
n 57 26 31 .04
dB, mean 6 SD 41.1 6 14.0 36.5 6 14.9 44.9 6 12.3
Range dB (minimum-maximum) 15-85 15-65 25-85
Preoperative AC PTA
n 62 28 34 .01
dB, mean 6 SD 49.1 6 16.0 43.8 6 16.4 53.4 6 14.5
Range dB (minimum-maximum) 20.6-95.0 20.6-79.4 32.5-95.0

Abbreviations: ABG, air-bone gap; AC, air conduction; COM, chronic otitis media; CWD, canal wall down; ICW, intact canal wall; PORP, partial titanium ossi-
cular prosthesis; PTA, pure-tone average; SRT, speech reception threshold; TORP, total titanium ossicular prosthesis.
a
Values are presented as number (%) unless otherwise indicated.

Long-Term Audiometric Outcomes

Figure 2. Preoperative air-conduction pure-tone average and
word recognition scores in patients with long-term follow-up.
Sixty-seven percent (94/140) of all cases achieved an ABG
20 dB at \6 months. PORP reconstructions achieved slightly
higher rates of success (75.5%, 40/53) compared with TORPs
(62.1%, 54/87), but this difference was not significant (P = .14).
The mean time to long-term follow-up was 51.6 6 21.6
months (minimum 2 years). Long-term hearing outcomes
are reported in Table 4; again, no differences were noted
when comparing audiometric outcomes between PORPs and
TORPs. The power of the performed test for the primary
outcome measure of interest, long-term postoperative ABG,
was 0.262 and below the desired power of 0.800.
The mean ABG at long-term follow-up (20.0 6 12.1 dB)
was improved compared with preoperative ABG (33.4 6 12.9
dB) (P \ .0001). Long-term postoperative SRT (29.9 6 15.1
dB) was also significantly better than preoperative SRT (41.1
6 14 dB) (P \ .0001). Long-term changes in AC PTA and
WRS after ossiculoplasty are presented in Figure 4. Mean
long-term AC PTA (35.3 6 16.1 dB) was significantly better
than preoperative AC PTA (49.1 6 16.0 dB) (P \ .0001). No
change in WRS was noted between preoperative (96.7% 6
6.8%) and long-term postoperative follow-up (96.9% 6 5.5%)
(P = .97).
Sixty percent of cases (37/61) achieved an ABG 20 dB
at the time of their last follow-up. Roughly two-thirds
(65.4%, 17/26) of PORPs achieved an ABG 20 dB, and
57.1% (20/35) reached this measure in the TORP group; no
difference was present between groups (P = .70).
1088 Otolaryngology–Head and Neck Surgery 154(6)

Table 3. Short-Term Audiometric Results.

Overall PORP TORP P Value

Postoperative ABG
n 140 53 87 .08
dB, mean 6 SD 18.4610.6 16.5 6 10.1 19.7 6 10.7
Range dB (minimum-maximum) 0 to 49.4 0.6 to 44.4 0 to 49.4
DABG
n 138 52 86 .10
dB, mean 6 SD 17.0615.4 14.2 6 15.3 18.7 6 15.3
Range dB (minimum-maximum) –18.1 to 49.4 –18.1 to 49.4 –13.8 to 48.8
Postoperative AC PTA
n 149 56 93 .15
dB, mean 6 SD 31.7615.2 30.1 6 16.0 32.3 6 14.7
Range dB (minimum-maximum) 5.0 to 75.0 10.0 to 71.3 5.0 to 75.0
Postoperative SRT
n 149 56 93 .39
dB, mean 6 SD 25.9615.4 24.8 6 15.8 26.6 6 15.2
Range dB (minimum-maximum) 0 to 70.0 0 to 70.0 5 to 70.0

Abbreviations: ABG, air-bone gap; AC, air conduction; PORP, partial titanium ossicular prosthesis; PTA, pure-tone average; SRT, speech reception threshold;
TORP, total titanium ossicular prosthesis.

Stability of Hearing from Short-Term to Long-Term

Follow-up
Patients included in this analysis had both short- and long-
term ABG data (n = 50). Paired testing revealed a signifi-
cant increase in ABG (3.4 dB) at the long-term follow-up
compared with initial postoperative follow-up (P = .03)
(Figure 5). When analyzed by type of prosthesis, a statisti-
cally significant increase in ABG at long-term follow-up
was evident within the PORP cohort (4.9 dB, P = .02) but
not in the TORP group (2.5 dB, P = .50). No difference was
noted in the percentage of patients achieving an ABG 20
at short- and long-term follow-up (67.1% vs 60%, P = .47).
A considerable number of patients were lost to follow-up,
which may bias results regarding long-term stability. In an
attempt to examine whether early postoperative results in
patients with long-term follow-up differed from those lacking
long-term follow-up, short-term ABG was compared between Figure 3. Short-term changes in air-conduction pure-tone average
these 2 cohorts; no differences were noted (P . .05). and word recognition scores after titanium ossiculoplasty.

Complications and Revision Surgery

The percentage of patients that ultimately underwent revision
ossiculoplasty by the senior surgeon was 15.4% (24/156). The
mean time from initial ossiculoplasty to revision ossiculoplasty
was 28.3 6 22.3 months. Five cases were revised secondary
to extrusion (3.2%), 6 due to recurrent cholesteatoma (3.8%),
6 for sequelae of chronic ear disease without cholesteatoma
(perforation, retraction) (3.8%), and 7 for a persistent conduc-
tive hearing loss (prosthesis displacement, fixed footplate)
(8.3%). Eleven revisions (45.8%) were performed .2 years
after the initial ossiculoplasty. Of these 11 cases, only 2 were
performed because of extruding prostheses.
There were no cases of a postoperative increase in BC PTA
greater than 15 dB. There were no cases of postoperative
facial weakness. One patient developed a hematoma postopera-
tively, necessitating evacuation and control of bleeding.
Discussion
Short-Term Outcomes
While the primary objective of this study was to describe
long-term outcomes and stability of titanium prostheses, short-
term results were included to provide a measure of the initial
technical success of ossiculoplasty. The observed postoperative
ABG of 18.4 dB is comparable to that (12.4-29.0 dB) reported
in the literature for titanium OCR.7,13-24 Similarly, achieve-
ment of an ABG 20 dB in 67.1% of cases falls within the
O’Connell et al 1089

Table 4. Long-Term Audiometric Outcomes.

Overall PORP TORP P Value

Postoperative ABG
n 61 26 35 .18
dB, mean 6 SD 20.0 6 12.1 17.6 6 9.5 21.8 6 13.6
Range dB (minimum-maximum) 3.1 to 58.8 4.4 to 35 3.1 to 58.8
DABG
n 53 23 30 .15
dB, mean 6 SD 12.3 6 15.4 8.5 6 14.0 15.2 6 18.6
Range dB (minimum-maximum) –26.3 to 58.8 –15 to 41.3 –26.3 to 58.8
Postoperative AC PTA
n 61 26 35 .29
dB, mean 6 SD 35.3 6 16.1 32.7 6 15.6 37.2 6 16.4
Range dB (minimum-maximum) 8.8 to 73.8 11.3 to 67.5 8.8 to 73.8
Postoperative SRT
n 64 29 35 .06
dB, mean 6 SD 29.9 6 15.1 26.0 6 14 33.1 6 15.3
Range dB (minimum-maximum) 5.0 to 65.0 5.0 to 65.0 10.0 to 65.0

Abbreviations: ABG, air-bone gap; AC, air conduction; PORP, partial titanium ossicular prosthesis; PTA, pure-tone average; SRT, speech reception threshold;
TORP, total titanium ossicular prosthesis.

obtaining acceptable long-term hearing outcomes after ossicu-

Figure 4. Long-term changes in air-conduction pure-tone average
and word recognition score after titanium ossiculoplasty.
range of reported rates (45.8%-81.4%).7,17-21,23-25 Our group
previously published a study regarding short-term hearing out-
comes of titanium ossiculoplasty. This earlier study reported
better hearing outcomes with a mean postoperative ABG of
15.4 dB and achievement of an ABG 20 dB in 77.1% of
cases.6 These differences are likely due to the fact that only
chronic ear patients were included in the present study,
whereas the prior report included patients with otosclerosis,
trauma, and congenital ossicular abnormalities.
Long-Term Outcomes
Long-term outcomes are ultimately of greatest interest to both
surgeons and patients. In patients with chronic ear disease,
loplasty poses certain challenges. Middle ear effusion, mucosal
inflammation, tympanic membrane retraction, cholesteatoma
recurrence, and scarring of the middle ear cleft with adhesion
formation or tympanosclerosis can manifest years after surgery
and predispose to less favorable outcomes.
A number of studies have reported long-term outcomes of
OCR using nontitanium prostheses. In such studies, mean
long-term postoperative ABG is reported to range between
12 and 21 dB, and success (ABG 20 dB) is described in
37% to 65% of cases.26-30 The long-term functional results of
titanium ossiculoplasty, however, remain unclear. This is
partly due to the shorter period of time that titanium has been
implemented in ossiculoplasty. But perhaps more important,
variable and inconsistent methods have been used in report-
ing long-term results. It is the opinion of the authors that for
outcomes to be considered long term, data should be col-
lected at least 2 years after OCR, preferably longer.
To our knowledge, the present study is the first to
describe hearing outcomes of both PORP and TORP ossicu-
loplasty with postoperative follow-up of at least 2 years in
patients exclusively with chronic otitis media. In this series,
a mean ABG of 20.0 dB was observed at an average follow-
up of 52 months. Long-term ABG closure of 12.3 dB was
observed. At the time of last follow-up, 60% of cases
achieved an ABG 20 dB. Hess-Erga et al31 reported out-
comes of titanium ossiculoplasty with a mean follow-up of
62 months. While this length of follow-up is commendable,
no minimum follow-up was specified and is a limitation.
Their results are nonetheless encouraging in that achieve-
ment of ABG  20 dB was attained in 60% and 73% of
patients with chronic otitis media without cholesteatoma
(n = 5) and with cholesteatoma (n = 40), respectively.
1090
Figure 5. When comparing short-term postoperative air-bone gap
(ABG) with long-term postoperative ABG, a significant increase in
ABG (3.4 dB) was noted (P = .04). Dots represent individual
patients, with lines connecting short-term and long-term follow-up
within patients.
A few studies have specifically examined outcomes of
TORP titanium ossiculoplasty at least 2 years after OCR.
Nevoux et al7 studied titanium TORPs in children with cho-
lesteatoma. At 2 years postoperatively, mean ABG was 22.5
dB, and 55% of patients achieved an ABG 20 dB. Five
years after OCR, they reported a mean ABG of 20.0 dB and
achievement of ABG 20 dB in 64% of patients. Iniguez-
Cuadra et al20 reported hearing outcomes with titanium
TORPs .2 years post-OCR; a mean ABG of 11.8 dB was
observed. In our cohort, titanium TORPs demonstrated
long-term mean ABG of 21.8 dB with 57.1% of cases
achieving ABG 20 dB. The superior ABG results observed
in Iniguez-Cuadra et al may be the result of including cases
with nonchronic ear pathology (eg, cerebrospinal fluid leak,
labyrinthine fistula, isolated conductive hearing loss, and
congenital ossicular malformations). As noted in the Hess-
Erga et al31 study, patients without chronic otitis media
undergoing OCR tend to do better than their counterparts
with chronic ear disease.
We also quantitatively assessed the stability of titanium
ossiculoplasty over time. In patients with both short- and
long-term follow-up, a small but statistically significant
increase in ABG (3.4 dB) was observed from early post-
operative audiometric evaluation to late postoperative test-
ing. As can be appreciated in Figure 5, one patient had
considerable worsening of ABG between short-term (18 dB)
and long-term (59 dB) follow-up. This patient had previ-
ously undergone 7 otologic surgeries elsewhere, and the
senior author performed revision canal wall-down mastoi-
dectomy with TORP placement. Initially, a good hearing
result was achieved. However, after initial follow-ups, sig-
nificant granulation formed at the level of the neotympa-
num, and subsequently partial extrusion of the prosthesis
developed, thus explaining the large increase in ABG.
Otolaryngology–Head and Neck Surgery 154(6)
The stability of PORPs and TORPs was examined sepa-
rately. Hearing significantly deteriorated over time within
the PORP cohort (4.9 dB), but there was no significant
change within the TORP group (2.5 dB). This finding was
somewhat surprising as we expected stability to be better
with PORPs given the presence of an intact stapes. One
possible explanation for this observation is that the stapes,
which is inherently present in patients with PORP, may
undergo erosion over time in patients with chronic ear dis-
ease. This would compromise tight coupling between
stapes and PORP and adversely affect the sound conduc-
tion mechanism. Alternatively, slight movement of a
PORP could result in changes in the axis or fulcrum of the
ossicular chain and affect sound transfer. Other studies
have also found that titanium TORPs remain stable over
time.20,32 It needs to be emphasized that there was signifi-
cant loss to follow-up in this series, which limits one’s
ability to draw definitive conclusions regarding long-term
stability. This potential bias should be recognized in inter-
preting our data regarding stability of implants beyond 2
years.
There are conflicting reports as to whether PORP or
TORP reconstruction is associated with better hearing out-
comes.6,16,17,24,25,33 In our study, no statistically significant
difference in hearing results was present between PORPs
and TORPs at either short- or long-term follow-up. Our
sample size, however, was small and underpowered to
detect differences in ABG between PORPs and TORPs, and
therefore differences may be present that were not apparent.
The incidence of potentially confounding clinical factors
(history of cholesteatoma, presence of a malleus, staged pro-
cedures, prior mastoidectomy) was compared between
PORP and TORP subgroups. No differences were noted for
any of these factors (Tables 1 and 2), and therefore any
potential bias introduced by these variables is unlikely.
The finding that nearly half of all revisions (11/24) were
performed greater than 2 years after ossiculoplasty high-
lights the importance of long-term follow-up. The rate of
extrusion deserves further mention as biocompatibility has
yet to be fully elucidated with titanium implants. The over-
all prosthesis extrusion rate (3.2%) falls within that reported
in the literature (0%-4%).4,7,14,17,20,24,34 Most long-term
revisions were due to either recurrent chronic otitis media
or conductive hearing loss. Interestingly, the rate of prosthe-
sis extrusion beyond 2 years postoperatively was very low
(1.3%), suggesting that titanium remains stable in the
middle ear environment for many years.
There are limitations to this study. Given its retrospective
design, only one-third of all patients undergoing titanium
ossiculoplasty had sufficient follow-up data to be included
in the analysis of long-term outcomes. Other long-term stud-
ies cite similar difficulty with high percentage yield of
patients returning for long-term follow-up.28 This potentially
introduces a bias of selective attrition in that patients
approaching longer follow-up times may become less likely
to seek medical attention for financial or personal reasons;
moreover, these patients may discontinue follow-up if they
O’Connell et al
are experiencing a good hearing result. However, an assess-
ment of our data demonstrates that there was no difference
between short-term hearing outcomes of those patients who
had a .2-year follow-up compared with patients who did not
have a .2-year follow-up. Last, while our mean postopera-
tive follow-up of 52 months is respectable, future studies
with even longer duration of postoperative follow-up are
needed to further examine the long-term stability of titanium
ossicular implants in the middle ear.
Conclusion
We report long-term hearing outcomes for a large series
of patients with chronic otitis media undergoing titanium
OCR by a single surgeon. With a minimum follow-up of
2 years (mean .4 years), the mean ABG was 20.0 dB
(17.6 dB for PORPs and 21.8 dB for TORPs). An ABG
20 dB was present in 60% of cases at long-term follow-
up (65.4% for PORPs and 57.1% for TORPs). A modest
deterioration in hearing (3.4 dB increase in ABG)
between short- and long-term follow-up was noted.
Titanium appears stable in the middle ear environment
long-term, as evidenced by a 3.2% rate of prosthesis
extrusion.
Author Contributions
Brendan P. O’Connell, study design, data acquisition, statistical
analysis, manuscript preparation, editing; Habib G. Rizk, study
design, data acquisition, interpretation of data, manuscript prepara-
tion, editing; Tanisha Hutchinson, study design, data acquisition,
interpretation of data, editing; Shaun A. Nguyen, study design,
interpretation of data, statistical analysis, editing; Paul R.
Lambert, study design, interpretation of data, manuscript prepara-
tion, editing.
Disclosures
Competing interests: Paul R. Lambert is an investigator for the fol-
lowing clinical trials: Otonomy OTO104 (Treatment for Meniere’s)
and Auris Medical (AM 101 Treatment for Tinnitus).
Sponsorships: None.
Funding source: None.
References
1. Zenner HP, Stegmaier A, Lehner R, Baumann I, Zimmermann
R.Open Tubingen titanium prostheses for ossiculoplasty: a pro-
spective clinical trial. Otol Neurotol. 2001;22:582-589.
2. Downs BW, Pearson JM, Zdanski CJ, Buchman CA, Pillsbury
HC.Revision ossicular reconstruction with the titanium Kurz
prosthesis. Laryngoscope. 2002;112:1335-1337.
3. Hillman TA, Shelton C.Ossicular chain reconstruction: tita-
nium versus plastipore. Laryngoscope. 2003;113:1731-1735.
4. Neff BA, Rizer FM, Schuring AG, Lippy WH.Tympano-ossi-
culoplasty utilizing the Spiggle and Theis titanium total ossi-
cular replacement prosthesis. Laryngoscope. 2003;113:1525-
1529.
5. Gardner EK, Jackson CG, Kaylie DM.Results with titanium ossi-
cular reconstruction prostheses. Laryngoscope. 2004;114:65-70.
1091
6. Coffey CS, Lee FS, Lambert PR.Titanium versus nontitanium
prostheses in ossiculoplasty. Laryngoscope. 2008;118:1650-
1658.
7. Nevoux J, Moya-Plana A, Chauvin P, Denoyelle F, Garabedian
EN.Total ossiculoplasty in children: predictive factors and long-
term follow-up. Arch Otolaryngol Head Neck Surg. 2011;137:
1240-1246.
8. Zeitler DM, Lalwani AK.Are postoperative hearing results better
with titanium ossicular reconstruction prostheses? Laryngoscope.
2010;120:2-3.
9. Colletti V, Fiorino FG, Sittoni V.Minisculptured ossicle grafts
versus implants: long-term results. Am J Otol. 1987;8:553-559.
10. Committee on Hearing and Equilibrium guidelines for the eva-
luation of results of treatment of conductive hearing loss.
American Academy of Otolaryngology—Head and Neck
Surgery Foundation, Inc. Otolaryngol Head Neck Surg. 1995;
113:186-187.
11. Gurgel RK, Popelka GR, Oghalai JS, Blevins NH, Chang KW,
Jackler RK.Is it valid to calculate the 3-kilohertz threshold by
averaging 2 and 4 kilohertz? Otolaryngol Head Neck Surg.
2012;147:102-104.
12. Gurgel RK, Jackler RK, Dobie RA, Popelka GR.A new stan-
dardized format for reporting hearing outcome in clinical
trials. Otolaryngol Head Neck Surg. 2012;147:803-807.
13. Gelfand YM, Chang CY.Ossicular chain reconstruction using
titanium versus hydroxyapatite implants. Otolaryngol Head
Neck Surg. 2011;144:954-958.
14. Orfao T, Julio S, Ramos JF, Dias CC, Silveira H, Santos M.
Audiometric outcome comparison between titanium prosthesis
and molded autologous material. Otolaryngol Head Neck Surg.
2014;151:315-320.
15. Yung M, Smith P.Titanium versus nontitanium ossicular
prostheses-a randomized controlled study of the medium-term
outcome. Otol Neurotol. 2010;31:752-758.
16. Martin AD, Harner SG.Ossicular reconstruction with titanium
prosthesis. Laryngoscope. 2004;114:61-64.
17. Schmerber S, Troussier J, Dumas G, Lavieille JP, Nguyen DQ.
Hearing results with the titanium ossicular replacement pros-
theses. Eur Arch Otorhinolaryngol. 2006;263:347-354.
18. De Vos C, Gersdorff M, Gerard JM. Prognostic factors in ossi-
culoplasty. Otol Neurotol. 2007;28:61-67.
19. Wolter NE, Holler T, Cushing SL, et al. Pediatric ossiculo-
plasty with titanium total ossicular replacement prosthesis.
Laryngoscope. 2015;125:740-745.
20. Iniguez-Cuadra R, Alobid I, Bores-Domenech A, Menendez-
Colino LM, Caballero-Borrego M, Bernal-Sprekelsen M.Type
III tympanoplasty with titanium total ossicular replacement
prosthesis: anatomic and functional results. Otol Neurotol.
2010;31:409-414.
21. Meulemans J, Wuyts FL, Forton GE.Middle ear reconstruction
using the titanium Kurz Variac partial ossicular replacement
prosthesis: functional results. JAMA Otolaryngol Head Neck
Surg. 2013;139:1017-1025.
22. Quaranta N, Zizzi S, Quaranta A.Hearing results using titanium
ossicular replacement prosthesis in intact canal wall tympano-
plasty for cholesteatoma. Acta Otolaryngol. 2011;131:36-40.
1092
23. Redaelli de Zinis LO.Titanium vs hydroxyapatite ossiculo-
plasty in canal wall down mastoidectomy. Arch Otolaryngol
Head Neck Surg. 2008;134:1283-1287.
24. Alaani A, Raut VV.Kurz titanium prosthesis ossiculoplasty—
follow-up statistical analysis of factors affecting one year hear-
ing results. Auris Nasus Larynx. 2010;37:150-154.
25. Truy E, Naiman AN, Pavillon C, Abedipour D, Lina-Granade
G, Rabilloud M.Hydroxyapatite versus titanium ossiculoplasty.
Otol Neurotol. 2007;28:492-498.
26. Shinohara T, Gyo K, Saiki T, Yanagihara N.Ossiculoplasty
using hydroxyapatite prostheses: long-term results. Clin
Otolaryngol Allied Sci. 2000;25:287-292.
27. Goldenberg RA, Driver M.Long-term results with hydroxyla-
patite middle ear implants. Otolaryngol Head Neck Surg.
2000;122:635-642.
28. Berenholz LP, Burkey JM, Lippy WH.Short- and long-term
results of ossicular reconstruction using partial and total plasti-
pore prostheses. Otol Neurotol. 2013;34:884-889.
Otolaryngology–Head and Neck Surgery 154(6)
29. Eleftheriadou A, Chalastras T, Georgopoulos S, et al. Long-
term results of plastipore prostheses in reconstruction of the
middle ear ossicular chain. ORL J Otorhinolaryngol Relat
Spec. 2009;71:284-288.
30. Yung M.Long-term results of ossiculoplasty: reasons for surgi-
cal failure. Otol Neurotol. 2006;27:20-26.
31. Hess-Erga J, Moller P, Vassbotn FS.Long-term hearing result using
Kurz titanium ossicular implants. Eur Arch Otorhinolaryngol. 2013;
270:1817-1821.
32. Fayad JN, Ursick J, Brackmann DE, Friedman RA.Total ossi-
culoplasty: short- and long-term results using a titanium pros-
thesis with footplate shoe. Otol Neurotol. 2014;35:108-113.
33. Siddiq MA, Raut VV.Early results of titanium ossiculoplasty
using the Kurz titanium prosthesis—a UK perspective. J
Laryngol Otol. 2007;121:539-544.
34. Dalchow CV, Grun D, Stupp HF.Reconstruction of the ossicu-
lar chain with titanium implants. Otolaryngol Head Neck Surg.
2001;125:628-630.