Clinical Performance Evaluation of a Personal Sound Amplification Product vs a Basic Hearing Aid and a Premium Hearing Aid.

Importance Hearing loss is a highly prevalent condition with multiple negative associated outcomes, yet few persons with hearing loss have hearing aids (HAs). Personal sound amplification products (PSAPs) could be an alternative low-cost solution to HAs, but data are lacking on the performance of PSAPs. Objective To evaluate the clinical efficacy of a PSAP by comparing its performance with that of a basic HA and a premium HA in participants with mild, moderate, and moderately severe hearing impairment. Design, Setting, and Participants A prospective, single-institution cohort study was performed with a total of 56 participants, including 19 with mild hearing loss, 20 with moderate hearing loss, and 17 with moderately severe hearing loss. All participants underwent 4 clinical hearing tests with each of the PSAP, basic HA, and premium HA, and all completed an evaluative questionnaire. Interventions All hearing devices (PSAP, basic HA, and premium HA) were applied by a clinician to prevent bias and order effects; participants were blinded to the device in use, and sequence of devices was randomized. Main Outcomes and Measures The study used the Korean version of the hearing in noise test, the speech intelligibility in noise test, listening effort measurement using a dual-task paradigm, pupillometry, and a self-rating questionnaire regarding sound quality and preference. These tests were administered under the following 4 hearing conditions: unaided hearing, use of PSAP, use of basic HA, and use of premium HA. Results The study included 56 participants with a mean age of 56 years (interquartile range, 48-59 years); 29 (52%) were women. In the mild and moderate hearing loss groups, there was no meaningful difference between PSAP, basic HA, and premium HA for speech perception (Cohen d = 0.06-1.05), sound quality (Cohen d = 0.06-0.71), listening effort (Cohen d = 0.10-0.92), and user preference (PSAP, 41%; basic HA, 28%; premium HA, 31%). However, for the patients with moderately severe hearing loss, the premium HA had better performance across most tests (Cohen d = 0.60-1.59), and 70% of participants preferred to use the premium HA. Conclusions and Relevance The results indicate that basic and premium HAs were not superior to the PSAP in patients with mild to moderate hearing impairment, which suggests that PSAPs might be used as an alternative to HAs in these patient populations. However, if hearing loss is more severe, then HAs, especially premium HAs, should be considered as an option to manage hearing loss.