Professional Documents
Culture Documents
Otolaryngology–
Head and Neck Surgery
Sponsorships or competing interests that may be relevant to content are dis- Received June 18, 2015; revised January 19, 2016; accepted January 29,
closed at the end of this article. 2016.
Abstract
S
ince the advent of ossiculoplasty in the 1950s, a wide
Objective. The primary objective is to report long-term hear- variety of materials have been used for ossicular chain
ing outcomes (.2 years) after titanium ossiculoplasty in reconstruction (OCR). Titanium ossicular implants
patients with chronic otitis media. were introduced in the 1990s, and their use is now wide-
Study Design. Case series with chart review. spread. Proponents of titanium implants credit the material’s
light weight, rigidness, and low impedance for its favorable
Setting. Tertiary care hospital. acoustic characteristics. Furthermore, the small size of tita-
Subjects and Methods. In total, 156 patients with chronic otitis nium prostheses and open head design enhances surgeon
media undergoing titanium ossiculoplasty were included. The pri- visualization and facilitates placement.
mary outcome measure was the long-term postoperative ABG. Most of the data regarding the success of titanium ossicu-
The stability of hearing over time was determined by comparing loplasty pertain to short-term hearing outcomes. In general,
short-term and long-term postoperative air-bone gap (ABG). early hearing results demonstrate reasonable closure of the
Secondary outcome measures included DABG, postoperative air-bone gap (ABG) with a low prosthesis extrusion rate.1-8
speech reception thresholds, air-conduction pure-tone average (AC Long-term outcomes of titanium ossiculoplasty, particularly
PTA), word recognition scores, and percentage of patients achieving in patients with chronic ear disease, are less clear. Such data
ABG 20 dB. Revision and extrusion rates were examined. are essential, as disease-specific factors related to chronic
otitis media may predispose to deterioration in hearing over
Results. At short-term follow-up (\6 months), mean post- time in this population.9 Residual cholesteatoma and seque-
operative ABG was 18.4 6 10.6 dB and AC PTA was 31.7 6 lae of persistent eustachian tube disease can take years to
15.2 dB; 67% of patients achieved ABG 20 dB. At long-term clinically manifest and may not be apparent in the early
follow-up (.2 years), mean ABG was 20.0 dB 6 15.4 and AC postoperative period.
PTA was 35.3 6 16.1 dB; 60% of patients achieved ABG 20. Therefore, the principal aim of this article is to report
At both short- and long-term follow-up, ABG and AC PTA long-term outcomes (.2 years) after titanium ossiculoplasty
were significantly improved compared with preoperative by the same surgeon in patients with chronic otitis media.
values. No difference in hearing outcomes was observed when The long-term stability of titanium prostheses will also be
comparing partial titanium ossicular prostheses (PORPs) to determined by comparing findings at short- and long-term
total titanium ossicular prostheses (TORPs) at either short- follow-up. We hypothesize that (1) long-term hearing results
or long-term follow-ups. In patients with both short- and long- and complication profiles will be favorable, and (2) only
term follow-up (n = 50), deterioration in hearing was noted modest deterioration in hearing will be observed with time.
(3.4 dB, P = .04). When analyzed by type of prosthesis, PORPs
demonstrated statistically significant deterioration in ABG over 1
time (4.9 dB, P = .02), while TORPs did not (2.5 dB, P = .50). Department of Otolaryngology, Vanderbilt University, Nashville,
Tennessee, USA
The long-term extrusion rate was 3.2%. 2
Department of Otolaryngology–Head and Neck Surgery, Medical
Conclusion. With a minimum follow-up of 2 years, titanium University of South Carolina, Charleston, South Carolina, USA
ossiculoplasty provides good long-term hearing results. This article was presented at the 2015 AAO-HNSF Annual Meeting and
Modest deterioration in hearing is noted over time. OTO EXPO; September 27-30, 2015; Dallas, Texas.
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.
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.
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.
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.
are experiencing a good hearing result. However, an assess- 6. Coffey CS, Lee FS, Lambert PR.Titanium versus nontitanium
ment of our data demonstrates that there was no difference prostheses in ossiculoplasty. Laryngoscope. 2008;118:1650-
between short-term hearing outcomes of those patients who 1658.
had a .2-year follow-up compared with patients who did not 7. Nevoux J, Moya-Plana A, Chauvin P, Denoyelle F, Garabedian
have a .2-year follow-up. Last, while our mean postopera- EN.Total ossiculoplasty in children: predictive factors and long-
tive follow-up of 52 months is respectable, future studies term follow-up. Arch Otolaryngol Head Neck Surg. 2011;137:
with even longer duration of postoperative follow-up are 1240-1246.
needed to further examine the long-term stability of titanium 8. Zeitler DM, Lalwani AK.Are postoperative hearing results better
ossicular implants in the middle ear. with titanium ossicular reconstruction prostheses? Laryngoscope.
2010;120:2-3.
Conclusion 9. Colletti V, Fiorino FG, Sittoni V.Minisculptured ossicle grafts
versus implants: long-term results. Am J Otol. 1987;8:553-559.
We report long-term hearing outcomes for a large series
10. Committee on Hearing and Equilibrium guidelines for the eva-
of patients with chronic otitis media undergoing titanium
luation of results of treatment of conductive hearing loss.
OCR by a single surgeon. With a minimum follow-up of
American Academy of Otolaryngology—Head and Neck
2 years (mean .4 years), the mean ABG was 20.0 dB
Surgery Foundation, Inc. Otolaryngol Head Neck Surg. 1995;
(17.6 dB for PORPs and 21.8 dB for TORPs). An ABG
113:186-187.
20 dB was present in 60% of cases at long-term follow-
11. Gurgel RK, Popelka GR, Oghalai JS, Blevins NH, Chang KW,
up (65.4% for PORPs and 57.1% for TORPs). A modest
Jackler RK.Is it valid to calculate the 3-kilohertz threshold by
deterioration in hearing (3.4 dB increase in ABG)
averaging 2 and 4 kilohertz? Otolaryngol Head Neck Surg.
between short- and long-term follow-up was noted.
2012;147:102-104.
Titanium appears stable in the middle ear environment
12. Gurgel RK, Jackler RK, Dobie RA, Popelka GR.A new stan-
long-term, as evidenced by a 3.2% rate of prosthesis
dardized format for reporting hearing outcome in clinical
extrusion.
trials. Otolaryngol Head Neck Surg. 2012;147:803-807.
13. Gelfand YM, Chang CY.Ossicular chain reconstruction using
Author Contributions
titanium versus hydroxyapatite implants. Otolaryngol Head
Brendan P. O’Connell, study design, data acquisition, statistical Neck Surg. 2011;144:954-958.
analysis, manuscript preparation, editing; Habib G. Rizk, study
14. Orfao T, Julio S, Ramos JF, Dias CC, Silveira H, Santos M.
design, data acquisition, interpretation of data, manuscript prepara-
Audiometric outcome comparison between titanium prosthesis
tion, editing; Tanisha Hutchinson, study design, data acquisition,
interpretation of data, editing; Shaun A. Nguyen, study design, and molded autologous material. Otolaryngol Head Neck Surg.
interpretation of data, statistical analysis, editing; Paul R. 2014;151:315-320.
Lambert, study design, interpretation of data, manuscript prepara- 15. Yung M, Smith P.Titanium versus nontitanium ossicular
tion, editing. prostheses-a randomized controlled study of the medium-term
outcome. Otol Neurotol. 2010;31:752-758.
Disclosures 16. Martin AD, Harner SG.Ossicular reconstruction with titanium
Competing interests: Paul R. Lambert is an investigator for the fol- prosthesis. Laryngoscope. 2004;114:61-64.
lowing clinical trials: Otonomy OTO104 (Treatment for Meniere’s) 17. Schmerber S, Troussier J, Dumas G, Lavieille JP, Nguyen DQ.
and Auris Medical (AM 101 Treatment for Tinnitus).
Hearing results with the titanium ossicular replacement pros-
Sponsorships: None.
theses. Eur Arch Otorhinolaryngol. 2006;263:347-354.
Funding source: None.
18. De Vos C, Gersdorff M, Gerard JM. Prognostic factors in ossi-
culoplasty. Otol Neurotol. 2007;28:61-67.
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