OTC Hearing Aids: Useful Lower-Cost Option for Some Patients

Nicola M. Parry, DVM

May 22, 2019

Over-the-counter (OTC) personal sound amplification products (PSAPs) may be useful lower-cost alternatives to hearing aids (HAs) for adults with mild to moderate hearing loss, a study published online May 16 in JAMA Otolaryngology–Head and Neck Surgery shows.

"The results indicate that basic and premium HAs were not superior to the PSAP in patients with mild to moderate hearing impairment," write Young Sang Cho, MD, Sungkyunkwan University School of Medicine, Seoul, South Korea, and colleagues.

"However, if hearing loss is more severe, then HAs, especially premium HAs, should be considered as an option to manage hearing loss," they write.

Age-related hearing loss is common, and HAs are the cornerstone of its management.

However, research shows that hearing loss often goes untreated; fewer than 20% of US adults with hearing loss report using HAs. The high cost of HAs is a substantial barrier to their use.

According to the authors, PSAPs are the audio equivalent of reading glasses. They are available over the counter, do not require a medical examination or fitting appointment, and are much less expensive than HAs. Prices of PSAPs range from $20 to $400.

Both HAs and PSAPs are wearable devices that improve the ability to hear sound, but only HAs can compensate for hearing loss. PSAPs are intended to help people who are without hearing loss to hear better in certain environments, such as recreational events.

Studies have suggested that PSAPs only slightly benefit patients who have mild to moderate hearing loss and that they do not offer the high-frequency gain necessary to benefit people with high-frequency hearing loss.

However, no comprehensive studies have been conducted on the performance of PSAPs, and there have been no reports regarding results of laboratory testing or responses by patients to questionnaires.

With this in mind, Cho and colleagues prospectively evaluated the comparative effectiveness of a PSAP, a basic HA, and a premium HA in various acoustic environments for patients with mild, moderate, and moderately severe hearing loss.

Their study included 56 adults (mean age, 56 years) who had never previously used a PSAP. All participants underwent four unaided clinical hearing tests using each of the three devices, and they completed a self-rating questionnaire.

The researchers used speech intelligibility in noise testing to evaluate speech perception and a dual-task paradigm and pupillometry to evaluate listening effort. The self-rating patient questionnaire was used to evaluate sound quality and user preference.

For patients with mild hearing loss and those with moderate hearing loss, there were no significant differences between the three devices with respect to 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 those with moderately severe hearing loss, the researchers found that the premium HA performed better than the other two devices on most tests (Cohen d = 0.60 – 1.59); 70% of these patients preferred the premium device.

The authors advise against applying these results to all HAs and PSAPs because the study did not examine different brands of each device type and did not include any long-term follow-up.

"Further verification of safety and a comparative study on the usefulness of PSAPs and HAs in real life are needed," Cho and colleagues write.

In an accompanying editorial, Nicholas S. Reed, AuD, Johns Hopkins University, Baltimore, Maryland, emphasizes that these results support previous data suggesting that adults with mild to moderate hearing loss may benefit from OTC devices. The results also reinforce that these devices may not benefit patients with more severe hearing loss, he says.

According to Reed, the study advances understanding of PSAPs from efficacy research into effectiveness work. The investigators took an important step in device research, he says, "by moving away from traditional measures and into subclinical listening effort tasks that could be more sensitive to differences between conditions."

He notes that OTC hearing devices could reshape hearing care in this country by removing barriers to hearing care and possibly by encouraging consumer technology companies to join the HA market, thus improving access and affordability of devices.

This study "is a step in the right direction of comparative effectiveness research," he concludes, "but more work is needed to (1) develop novel hearing care delivery models, (2) understand long-term effects of over-the-counter models, (3) determine predictors of patient success, (4) provide evidence-based criteria for user referrals for care, and (5) inform future policy such as Medicare-covered hearing support services."

The authors of the study have disclosed no relevant financial relationships. Reed has served as a consultant for Helen of Troy and as a scientific advisory board member (nonfinancial) of Shoebox Inc.

JAMA Otolaryngol Head Neck Surg. Published online May 16, 2019. Abstract, Editorial

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