
In recent years, the Food and Drug Administration (FDA) has altered regulations regarding hearing aids, allowing for over-the-counter hearing aid sales. Prior to October of 2022, over-the-counter hearing aids were not permitted for use, only prescription hearing aids that were fit and dispensed by a licensed hearing healthcare provider were permitted.
The new category of devices, known as "OTC hearing aids" has created a considerable amount of confusion among patients who wonder whether to visit an audiologist or to go the "DIY" route, so to speak, and purchase devices over-the-counter.
Fortunately, a new randomized clinical trial, one of the most rigorous types of research design, provides clear answers, suggesting that while all hearing options offer benefit, maximizing a person's outcome and benefit depends less on the device's price tag and more on the quality of the fitting and ongoing service that configures the hearing aids and guides patients in their use.
In, "Hearing Aid Service Models, Technology, and Patient Outcomes A Randomized Clinical Trial", recently published in JAMA Otolaryngology–Head & Neck Surgery (Vol. 151, No. 7), researchers sought to determine the effect of two main factors on patient outcomes among 295 adults (age 55+) with mild to moderate hearing loss:
High-end (advanced features) versus low-end HAs (same generation).
Using data collected from the 295 study participants using detailed questionnaires, the most critical finding was the clear benefit of the combination of prescription hearing aids dispensed by an audiologist and follow-up care with an audiologist. The AUD service model produced significantly better overall patient outcomes than both the OTC+ and OTC models.
Interestingly, the study also found no significant difference in general patient-reported outcomes between high-end and low-end hearing aids.
This suggests that for individuals with mild to moderate hearing loss, the higher costs associated with advanced features in a high-end device may not translate into a measurable overall improvement in daily life compared to a more basic, low-end device of the same technology generation. This lack of difference does not mean technology is irrelevant, but rather that the clinical fitting process and working with your audiologist to choose the right technology level for you is what truly unlocks a device's potential.
The study findings illustrate what we have always known at Aberdeen Audiology: If you are considering a hearing aid, the expertise of your audiologist is invaluable. Personalized fitting, best-practice care, and ongoing support maximize the effectiveness of your device—regardless of whether it's a high-end or a low-end model.