Dive Brief:

• An over-the-counter hearing aid performed comparably to an audiologist-fitted device in a small, short clinical trial.
• The study, which was funded by the maker of the OTC hearing aid, randomized 68 adults with self-described mild to moderate hearing loss to either self-fitting or audiologist-fitting of a hearing aid. Six weeks later, subjects in the two groups performed comparably on hearing tests.
• The study, published in a JAMA journal on Thursday, suggests that people can choose more affordable, accessible self-fitted hearing aids without compromising on results. However, the size and duration of the clinical trial may limit the conclusions that can be drawn, the study found.

Dive Insight:

The liberalization of the rules on hearing aids last year triggered a wave of launches of OTC devices that undercut incumbent products on price, and freed people with mild or moderate hearing loss from needing to visit audiologists for fittings. Still, the lack of head-to-head comparisons of the old and new devices has spurred questions about clinical effectiveness. 

To address the knowledge gap, hearX group, the company behind Bose-partnered OTC hearing-aid company Lexie, funded a clinical trial that enrolled people in South Africa last year. The study compared changes in the hearing of patients with the self-fitted and audiologist-fitted Lexie Lumen hearing aids. 

Two weeks after fitting, the study found “meaningfully better performance” in the self-fitted group on a background noise assessment and on the self-reported Abbreviated Profile of Hearing Aid Benefit (APHAB) global score. The primary endpoint used APHAB. However, by week six the differences between the two cohorts had disappeared. Self-fitted hearing aids performed as well as audiologist-fitted devices, according to the report. 

The findings suggest that consumers that follow Lexie’s commercially supplied instructional material and accompanying smartphone application can fit the Lumen device as effectively as audiologists working to best practices. That conclusion comes with some caveats. 

As the authors of the paper note, the clinical trial was not blinded, only studied one device and fitting method and enrolled too few participants to determine if the results of self-fitting vary across demographic groups. People who are less familiar with digital devices may struggle with self-fitting but the study was too small to test that idea, according to the paper. The average age in the self-fitting group was 62 years.