PP325 - Verification and Validation of Direct to Consumer Hearing Devices

Abstract: Current technology has allowed the development of advanced Direct to Consumer (D2C) hearing devices. What remains unanswered is whether they can provide adequate amplification and the patients’ perceived benefit. This study aimed to verify and validate objective and subjective outcomes of D2C devices and a traditional hearing aid. Twenty-two subjects were recruited. Real-ear verification of all devices’ output were compared to NAL-NL2 targets. Validation from patients was measured by questionnaries. Results provided evidence of the effectiveness and efficacy of D2C devices.

Summary: Rationale: Current developments in advanced consumer electronics have allowed manufacturers to develop self-adjustment algorithms as an integral part of their technology in the so called Direct to Consumer (D2C) hearing devices. Such devices are thought to be market disruptors as they may change how patients with hearing loss, clinicians, and the industry operate and interact with each other in the future. However, questions remain about the clinical efficacy and effectiveness of such devices/approaches compared to current standard of care.

Objectives: The purpose of this study was to measure outputs from two D2C devices on the market and a traditional hearing aid (HA), and to examine whether these devices provide adequate sound amplification relative to known best-practice prescription targets (NAL-NL2), along with patients’ perceived benefit wearing them.

Design: Twenty-two subjects were recruited. Two D2C devices (Eargo and Bose) and one premium level Receiver-In-the-Canal (RIC) traditional hearing aid (“big five”) were used. Patients followed self-adjusting procedures provided by the D2C manufacturers. Fitting of traditional HA was performed by experienced clinicians with a non-real-ear “first-fit” condition and a real-ear assisted “best-fit” condition. Output verification of all three devices were performed by real-ear measurements with Audioscan Verifit 2 and compared to NAL-NL2 targets based on the patients’ hearing loss. Validation of the fittings was measured by questionnaries on various aspects of the devices’ sound quality and patient satisfaction.

Results: Real-ear verification of the Eargo device showed significantly higher Speech Intelligibility Index (SII) and lower target Root Mean Square Error (RMSE) than “first-fit” premium hearing aids across different input sound levels. With real-ear assisted best practice fitting performed by Audiologists, however, traditional premium hearing aids provided significantly higher SII and lower RMSE than both Eargo and Bose devices. Between the two D2C devices, Eargo provided better gains compared to targets than Bose, but the differences were not significant based on number of patients in this study. Subjective validation obtained from patients showed no significant differences between all three devices, for the majority of the questions asked.

Conclusions: Taken together, the results demonstrated the efficacy and effectiveness of self-adjusting D2C devices providing adequate amplification for those with mild-to-moderate hearing loss. We further demonstrated the importance of the role well-trained Audiologists with best practice plays in providing hearing health care to patients in need. The results of this study may inform future design and development of self-adjusting D2C and/or OTC hearing aid strategies grounded in principles of hearing science and clinical audiology.