To assess the safety, stability, and performance of the broad-spectrum, light-based contact hearing device (CHD) on listeners with hearing impairment.Study Design
Single-site research and development facility.Participants
Thirteen participants 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 4 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 (functional gain), maximum gain before feedback, tympanic membrane damping, 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 participants’ 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 to 110 dB SPL in the range of 0.25 to 10 kHz, 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 92% of participants (11/12).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.