Revision tympanoplasty including anterior perforations and lateralization of grafts.

Not long ago, the restoration of a perforated tympanic membrane by grafting over an air-containing tympanic cavity seemed impossible. Fortunately, successful results are so consistent and universal today that restoration of the tympanic membrane is expected, and a failure calls for careful evaluation as to "why". If known principles are observed, few complications need occur. Usually, complications are the result of either the choice and placement of the graft used in the repair, or the presence of unresolved upper respiratory pathology. When revision tympanoplasty is necessary, use of the underplay fascial graft technique, properly applied, usually can solve any difficult problems.

Biomechanical influences of magnetic resonance imaging on the SOUNDTEC Direct System implant.

OBJECTIVE: The purpose of this study was to measure the forces experienced by the SOUNDTEC Direct System magnetic implant during 0.3-T MRI. STUDY DESIGN: Torsional and linear forces imposed on 8 implants were measured by using calibrated neurologic Von Frey hairs and were compared with finite-element analysis predictions and the forces required to separate the incudostapedial joints of unpreserved temporal bones. An implanted embalmed autopsy specimen was also examined before and after 1.5-T MRI. RESULTS: Peak linear force at the orifice of the MRI core measured 0.51g (+/-0.2 SD). Maximum torque occurred at the MRI core center and measured 11.4g-cm (+/-1.2 SD). The mean torque required to separate the incudostapedial joints of 12 unpreserved temporal bones was 33.8g-cm (+/-20.4 SD). The autopsy specimen sustained a 1.5-T MRI scan without disruption of the ossicular chain or explantation. CONCLUSIONS: Physical and mechanical testing of the SOUNDTEC implant indicates that the structural integrity of the ossicles will be maintained during 0.3-T MRI of the human head.

Middle ear electromagnetic semi-implantable hearing device: results of the phase II SOUNDTEC direct system clinical trial.

OBJECTIVE: To assess the safety and efficacy of the SOUNDTEC Direct System, a partially implantable electromagnetic middle ear hearing device. STUDY DESIGN: Food and Drug Administration Phase II clinical trial of 103 patients at 10 sites across the United States. SETTING: Tertiary referral medical centers. PATIENTS: Individuals with bilateral moderate to moderately severe sensorineural hearing impairment who had worn optimally fit hearing aids for at least 45 days. INTERVENTIONS: Therapeutic intervention included implantation of a 27-mg neodymium iron boron magnet encased in a laser-welded titanium canister onto the incudostapedial joint, followed, after a 10-week healing period, by fitting with a deep earmold coil assembly and activation of the sound processor. MAIN OUTCOME MEASURES: Functional gain, speech recognition in quiet and noise, articulation index scores, perceived aided benefit, sound quality judgments, satisfaction, and presence of feedback and occlusion with the Direct System were compared with those of the patients' optimally fit hearing aid. RESULTS: The results of this multicenter clinical trial were submitted to the Food and Drug Administration on April 13, 2001, and are presented here. The results with the use of the SOUNDTEC Direct System compared with an optimally fit hearing aid provided an average 7.9-dB increase in functional gain in the speech frequencies (500-4,000 Hz) and a 9.6 dB gain in high frequencies (2,000, 3,000, and 4,000 Hz). There was a statistically significant average increase of 5.3% in speech discrimination. The mean speech perception in noise test score was improved, but the improvement was not statistically significant. Subjective tests using abbreviated profile of hearing aid benefit and the Hough Ear Institute Profile demonstrated scores statistically improved over the hearing aid condition. These subjective tests measured areas such as the presence of occlusion and feedback, speech quality judgments, device preference, and perceived aided benefit. CONCLUSIONS: The results of this Phase II clinical trial demonstrate that the SOUNDTEC Direct System provided statistically significant reduction in feedback and occlusive effect as well as a statistically significant improvement in all the following categories: functional gain, articulation index scores, speech discrimination in quiet, perceived aided benefit, patient satisfaction and device preference over the patient's optimally fit hearing aid.

Homograft microlathed femur prosthesis in stapedectomy.

The use of homografts in ossiculoplasty has been well documented in the literature. In the early 1980s, nonossicular homograft otic capsule bone was used as a prosthetic material in stapedectomy. We began using homograft femur as a prosthetic material in the early 1990s. In this article, we report the results of a retrospective study of the use of homograft femur prostheses. A series of 300 stapedectomies was performed between Aug. 24, 1992, and Jan. 20, 2000. Total footplate removal with preservation of the posterior crus was our procedure of choice. However, in 116 of these cases, the posterior crus could not be used, and a homograft femur prosthesis was substituted. For these prostheses, all homograft femurs were obtained from the American Red Cross. All prostheses were prepared in the bone laboratory and stored in the bone bank until needed. After an adequate period of follow-up, we tabulated our results. We found that in 89 of 113 cases (78.8%) available for follow-up, the air-bone gap was completely closed. In addition, the air-bone gap was closed to within 5 dB in 11 patients (9.7%) and closed to within 10 dB in five patients (4.4%). In all, 105 of the 113 homograft femur prosthetic procedures (92.9%) resulted in a successful outcome.