Knoetze Megan, Manchaiah Vinaya, Cormier Kayla, Schimmel Carly, Sharma Anu, Swanepoel De Wet
Department of Speech-Language Pathology and Audiology, University of Pretoria, Lynnwood Road & Roper Street, Pretoria 0028, South Africa.
Virtual Hearing Lab, a Collaborative Initiative Between the University of Colorado School of Medicine, Aurora, CO 80045, USA, and the University of Pretoria, Pretoria, South Africa.
Audiol Res. 2025 Feb 13;15(1):17. doi: 10.3390/audiolres15010017.
To investigate the gain provided by self-fitting over-the-counter (SF-OTC) hearing aids compared to clinical NAL-NL2 targets, the differences between various FDA-approved SF-OTC devices, and potential changes in gain over time.
Two experiments were conducted: (1) a cross-sectional comparison of six SF-OTC hearing aids (n = 43) and (2) a longitudinal evaluation of gain within five days of self-fitting and four additional time points (n = 15). Real-ear measurements (REMs) were used to measure gain.
SF-OTC hearing aid gain corresponded with 10 dB SPL but not 5 dB SPL criteria from NAL-NL2 targets. Differences between NAL-NL2 targets and gain did not differ significantly between devices. There were no significant changes in gain over time for any input level.
SF-OTC hearing aids generally provide user-selected gain levels lower than clinical targets, particularly at higher frequencies. The gain remains stable over time, indicating limited user adjustment after initial fitting. OTC hearing aid manufacturers should consider implementing fitting algorithms that allow for gradual user acclimatization.
研究与临床NAL-NL2目标相比，自适配非处方（SF-OTC）助听器所提供的增益、各种FDA批准的SF-OTC设备之间的差异以及增益随时间的潜在变化。
进行了两项实验：（1）对六种SF-OTC助听器（n = 43）进行横断面比较，以及（2）在自适配后五天内和另外四个时间点对增益进行纵向评估（n = 15）。采用真耳测量（REM）来测量增益。
SF-OTC助听器增益符合NAL-NL2目标中10 dB SPL的标准，但不符合5 dB SPL的标准。设备之间，NAL-NL2目标与增益之间的差异无显著差异。对于任何输入水平，增益随时间均无显著变化。
SF-OTC助听器通常为用户提供低于临床目标的增益水平，尤其是在高频段。增益随时间保持稳定，表明初次适配后用户调整有限。非处方助听器制造商应考虑实施允许用户逐渐适应的适配算法。
