The argon laser microscope recently developed by the author is used to vaporize the stapes tendon, the posterior crus and a rosette of holes in the stapes footplate in the surgical treatment of otosclerosis. An autogenous vein--stainless steel piston assembly is used to reconstruct the stapes portion of the ossicular chain. The surgical technique and results in a preliminary series of 11 patients are reported. Rationale and advantages over conventional stapedectomy are discussed.
Objective
To assess the safety, stability, and performance of the broad spectrum, light based Contact Hearing Device (CHD) on listeners with hearing impairment.
Study Design
Feasibility study.
Setting
Single-Site Research and Development Facility.
Subjects
Thirteen subjects with symmetric mild to severe sensorineural hearing impairment had the CHD placed bilaterally.
Intervention
A custom-molded light activated Tympanic Contact Actuator (TCA) was placed into each ear by a physician, where it stayed in contact with the umbo and a portion of the medial wall of the ear canal for four months. Each CHD was calibrated and programmed to provide appropriate broad-spectrum amplification.
Main Outcome Measures
Safety was determined through routine otologic examinations. Aided and pre-TCA-insertion unaided audiometric thresholds, Reception Threshold for Sentences (RTS), and Abbreviated Profile of Hearing Aid Benefit (APHAB) measurements were made to characterize system performance as well as the benefits of amplification via the CHD.
Results
The TCAs remained on subjects’ ears for an average total of 122 days, without causing signs of inflammation or infection, and there were no serious device-related adverse events. Measured average maximum output of 90–110 dB SPL in the 0.25–10 kHz range, average maximum gain before feedback of 40 dB, and functional gain through 10 kHz show extended bandwidth broad spectrum output and gain. RTS results showed significant aided improvements of up to 2.8 dB, and APHAB results showed clinically significant aided benefits in 11/12 (92%) subjects.
Conclusion
The safety, stability, and performance demonstrated in this initial 4-month study suggest that the CHD may offer a feasible way of providing broad-spectrum amplification appropriate to treat listeners with mild to severe hearing impairment.
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