Semi-implantable electromagnetic middle ear hearing device for moderate to severe sensorineural hearing loss.

Despite the many improvements in hearing aid technology, conventional hearing aids continue to have significant limitations, which has led to increased interest in implantable hearing devices. The SOUNDTEC Direct Drive Hearing System for moderate to moderately severe sensorineural hearing loss is one such device. In this article the authors present results on five individuals enrolled in a Food And Drug Administration Phase I feasibility study.

Mass loading on the ossicles and middle ear function.

The middle ear as a levered vibrating system for sound transmission from the external to the inner ear is affected by changes in ossicular chain mass. Mass loading of the ossicles may impair ossicular dynamics and sound transmission to the inner ear. It is incumbent on otologic surgeons and researchers of middle ear mechanics to consider the mass loading effect on middle ear function in clinical and physiological applications. The residual hearing and frequency response can change after surgery or implantation of middle ear prostheses. We conducted experiments on mass loading effects on the middle ear transfer functions by using laser Doppler interferometry and a human temporal bone model. Two implant mass loading conditions were tested on 17 fresh or fresh-frozen temporal bones and compared with the unloaded condition for the frequencies 250 to 8,000 Hz. The results show that the linearity of the middle ear function did not change, although displacement of the stapes footplate decreased after the increased masses were placed on the incudostapedial joint. The greater the mass of the implant, the less displacement was measured at the stapes footplate. We conclude that there is a quantitative limit to increased mass on the ossicular chain above which the mass will remarkably impair hearing thresholds.

Early clinical results: SOUNDTEC implantable hearing device phase II study.

OBJECTIVE: To assess the safety and efficacy of a new semi-implantable electromagnetic hearing device, the SOUNDTEC Direct Drive Hearing System (DDHS), and to compare its performance with that of subjects' previously worn, optimally fit hearing aids. Preliminary results for the first 10 subjects are presented. STUDY DESIGN: The protocol specified in the Investigational Device Exemption is used in this ongoing FDA phase II 100-subject multicenter clinical trial. METHODS: For baseline, each subject is tested wearing his or her own optimally fit hearing aid in the ear to be implanted. Six-month postoperative outcome measures using the SOUNDTEC DDHS are compared with the baseline. Multiple objective and subjective outcomes (as listed under Results) were measured. RESULTS: When compared with the subjects' optimally fit hearing aids, the SOUNDTEC DDHS provided an average improvement of 52% in functional gain (250-6000 Hz), 22% in aided thresholds, 3.8% for speech discrimination in quiet, 17% for speech in noise, 13.1% in articulation index scores, 28% in aided benefit, 27.3% in sound quality of speech, and a 16.7% increase in overall subject satisfaction. In addition, with the SOUNDTEC DDHS, subjects reported absence of acoustic feedback, little or no occlusive effects, and more natural sound perception. CONCLUSION: Analysis of data on the first 10 subjects using the SOUNDTEC DDHS indicates positive outcomes regarding safety and efficacy, although the small sample size is not sufficient to permit valid statistical inferences to be drawn from our preliminary data. Results also demonstrate improvement in performance compared with the subjects' optimally fit hearing aids and an improvement in quality of life as demonstrated by objective and subjective tests and measures.

Stapedectomy. Causes of failure and revision surgery in otosclerosis.

The greatest chance of success in stapedectomy is at the time of the initial procedure. Complications are compounded and successes markedly decreased when revision surgery is attempted. The most common pitfalls encountered in stapedectomy are reviewed in this article. Principles of surgery that have minimized complications and decreased the need for revision procedures in the authors' practices are outlined. Guidelines helpful when considering revision surgery also are presented and specific indications are addressed.

The patulous eustachian tube: management options.

The patulous eustachian tube is a benign, yet annoying condition that may be over-looked or misdiagnosed. It is frequently associated with peritubal atrophy, and usually responds to conservative measures such as weight gain or mucus-producing agents. In patients not responding to these measures, a variety of surgical options are available. We have been using a technique that avoids elevating a tympanomeatal flap, is reversible, and is effective. This technique, as well as other surgical options, are reviewed. The advantages and disadvantages inherent in them are discussed.