A study published in the Journal of the American Medical Association (JAMA) Otolaryngology–Head & Neck Surgery has demonstrated the effectiveness of over-the-counter (OTC) hearing aids. The research, one of the first of its kind, showed that for people with mild to moderate hearing loss, self-fitting OTC hearing aids provide equal benefits at a much lower price than audiologist-fitted ones.

Lexie Lumen hearing aids, a commercially available hearing aid in the US, were given to 35 participants and instructed to self-fit. Compared to 33 participants that were given the same audiologist-fitted devices, the self-fitting group saw comparable benefits after six weeks of use. 32 participants from each group were included in the analysis by measuring self-reported benefits, according to the Abbreviated Profile of Hearing Aid Benefit (APHAB). 

A limitation of the study, however, was that it compared the same device across two fitting regimes. Further research will be beneficial to compare the widespread suitability of OTC hearing aids. Nevertheless, the demonstration of hearing aid effectiveness that does not require multiple audiologist appointments is an important step in the OTC market.

Indiana University professor Larry E Humes said: “This randomised controlled trial adds significantly to the growing evidence of positive outcomes attainable with high-quality OTC hearing aids accompanied by well-conceived approaches to self-fitting and user support.

 “The positive user benefits obtained should be welcome news to the millions of adults with mild-to-moderate hearing loss in need of hearing assistance.”

In August 2022, the US Food and Drug Administration (FDA) approved a new category of self-fitting hearing aids to be sold OTC, with the devices available in stores from October. The approval expanded access to individuals with hearing loss as OTC hearing aids cost less than a quarter of the price of their traditional, prescription counterparts, states the April 13 press release.

Despite the positive research, analysis by GlobalData states that the OTC hearing aid market will challenges in its growth. A main one of which is the reluctance of patient uptake – with many older patients, who compose the majority of the hearing loss cases, showing a desire to maintain an earlier lifestyle and avoid social stigma with visible hearing facilitation devices.