Abstract
The objective of this study was to test the ability to achieve, maintain, and subjectively benefit from extended high-frequency amplification in a real-world use scenario, with a device that restores audibility for frequencies up to 10 kHz. A total of 78 participants (149 ears) with mild to moderately-severe sensorineural hearing loss completed one of two studies conducted across eight clinical sites. Participants were fitted with a light-driven contact hearing aid (the Earlens system) that directly drives the tympanic membrane, allowing extended high-frequency output and amplification with minimal acoustic feedback. Cambridge Method for Loudness Equalization 2 - High Frequency (CAM2)-prescribed gains for experienced users were used for initial fitting, and adjustments were made when required according to participant preferences for loudness and comfort or when measures of functional gain (FG) indicated that more or less gain was needed. Participants wore the devices for an extended period. Prescribed versus adjusted output and gain, frequency-specific FG, and self-perceived benefit assessed with the Abbreviated Profile of Hearing Aid Benefit, and a custom questionnaire were documented. Self-perceived benefit results were compared with those for unaided listening and to ratings with participants' own acoustic hearing aids. The prescribed low-level insertion gain from 6 to 10 kHz averaged 53 dB across all ears, with a range from 26 to 86 dB. After adjustment, the gain from 6 to 10 kHz decreased to an average of 45 dB with a range from 16 to 86 dB. Measured FG averaged 39 dB from 6 to 10 kHz with a range from 11 to 62 dB. Abbreviated Profile of Hearing Aid Benefit results revealed a significant improvement in communication relative to unaided listening, averaging 28 to 32 percentage points for the background noise, reverberation, and ease of communication subscales. Relative to participants' own hearing aids, the subscales ease of communication and aversiveness showed small but significant improvements for Earlens ranging from 6 to 7 percentage points. For the custom satisfaction questionnaire, most participants rated the Earlens system as better than their own hearing aids in most situations. Participants used and reported subjective benefit from the Earlens system. Most participants preferred slightly less gain at 6 to 10 kHz than prescribed for experienced users by CAM2, preferring similar gains to those prescribed for inexperienced users, but gains over the extended high frequencies were high relative to those that are currently available with acoustic hearing aids.
Highlights
Most conventional hearing aids provide useful gain for frequencies up to 4 to 5 kHz (Moore et al 2001; Aazh et al 2012; Struck & Prusick 2017)
Abbreviated Profile of Hearing Aid Benefit results revealed a significant improvement in communication relative to unaided listening, averaging 28 to 32 percentage points for the background noise, reverberation, and ease of communication subscales
Most participants preferred slightly less gain at 6 to 10 kHz than prescribed for experienced users by CAM2, preferring similar gains to those prescribed for inexperienced users, but gains over the extended high frequencies were high relative to those that are currently available with acoustic hearing aids
Summary
Most conventional hearing aids provide useful gain for frequencies up to 4 to 5 kHz (Moore et al 2001; Aazh et al 2012; Struck & Prusick 2017). Despite the availability of a suitable fitting method, challenges arise in achieving sufficient audibility at extended HFs with conventional acoustic hearing aids, due to device limitations in bandwidth and output, and problems with acoustic feedback. For this reason, tests of the benefit of extended HF amplification have been largely limited to the laboratory. A relatively new device, the Earlens system (Earlens Corporation, Menlo Park, CA) (Fay et al 2013; Gantz et al 2017), has overcome this limitation
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