Self-Fitting OTC Hearing Aids Perform Well in Clinical Trial

Can over-the-counter (OTC) hearing aids work as well as professionally fit hearing aids? That question has been top-of-mind following the FDA's October 2022 approval of the new class of products for adults with mild to moderate hearing loss. Since then, dozens of OTC hearing aids have become available, some with branding from the likes of Sony, Bose, Jabra, and HP—and often in partnership with global hearing aid manufacturers.

A new study published in the April 13 online edition of JAMA Otolaryngology-Head and Neck Surgery suggests that self-fitting OTC hearing aids, when paired with good online support, do have the potential to work as well as the prescription-fit hearing aids dispensed by audiologists and hearing aid specialists.

In a randomized clinical effectiveness trial, self-fitting Lexie Lumen OTC hearing aids that users programmed for themselves performed as well as the same hearing aids programmed by audiologists with professional fitting software.

The trial, performed by three research audiologists affiliated with the University of Pretoria in South Africa, provided 32 patients with the OTC hearing aids and a Lexie smartphone self-fitting app enabling them to test their own hearing levels and to program the hearing aids themselves. An additional 32 patients were given the same hearing aids but had their hearing tested in person by the audiologists, who programmed them with professional fitting software.

Over a six-week period, OTC users were able to adjust their hearing aids with the app and also had access to Lexie Hearing’s online and remote telehealth support services. The second group, wearing the hearing aids programmed by professionals, had ongoing access to their audiologists for hands-on support. At the end of six weeks, users across both groups reported comparable improvements in their hearing and satisfaction with their hearing aids.

Effective hearing enhancement

The study concluded that under the right conditions, self-fitting OTC hearing aids can be programmed by the user well enough to enable effective hearing enhancement:

In this randomized clinical effectiveness trial, self-fitting OTC hearing aids with remote support yielded outcomes at six weeks post-fitting comparable to those of hearing aids fitted using audiologist best practices. These findings suggest that self-fitting OTC hearing aids may provide an effective intervention for mild-to-moderate hearing loss.

Outcomes were measured using the self-reported Abbreviated Profile of Hearing Aid Benefit and standard audiology tests including an abbreviated speech-in-noise test.

The results suggest that the principal benefits promised by OTC hearing aids—access to more affordable quality hearing assistance—are becoming more widely available to consumers with mild-to-moderate hearing loss.

Product quality and post-sale support are key

However, not all OTC hearing aids are created equal, with many offering lesser product quality and poor customer support in return for extremely low prices. Therefore the study's findings shouldn't be taken as an endorsement for the performance of the entire new class of OTC hearing aids.

But the study does indicate that product quality and extensive remote customer support during the acclimation process after the initial fitting can be effective for OTC hearing aid users in the same way they are key to the success of prescription hearing aids programmed in the audiologist's office:

• Product quality: Lexie Lumen hearing aids, priced at $799, are medical-grade devices that receive positive reviews from users. HearingTracker named Lexie Lumen one of the 10 best over-the-counter hearing aids for 2023.
• Customer support: Lexie Hearing provides extensive telehealth and phone support to customers who buy its OTC hearing aids. Support includes coaching on the setup, fitting with the smartphone app, and remote follow-up sessions to assist with program updates via the app as customers get used to their hearing aids.

What's the takeaway for consumers searching for more affordable hearing loss solutions? There are high-quality OTC products are out there for you, but only if you do your homework. It's important to seek out the best products with self-fitting software apps that get good reviews. And make sure the supplier offers ongoing remote after-sale support over the phone or by video conference.