OTC Hearing Devices Effective Alternative for Some, Study Shows

Troy Brown, RN

July 04, 2017

Inexpensive personal sound amplification products (PSAPs) can be almost as effective as costly hearing aids for those with mild to moderate hearing loss, a small study has found. Three of five PSAPs tested improved hearing to within 5 percentage points of the hearing aid, but one made hearing worse than using nothing at all.

Nicholas S. Reed, AuD, from the Department of Otolaryngology–Head and Neck Surgery, Johns Hopkins School of Medicine, Baltimore, Maryland, and colleagues published their findings online July 4 in JAMA.

"Results lend support to current national initiatives from the National Academies, White House, and bipartisan legislation requesting that the US Food and Drug Administration create a new regulatory classification for hearing devices meeting appropriate specifications to be available over the counter," the authors write.

The study included a convenience sample of 42 individuals aged 60 to 85 years (mean age, 71.6 years) with mild to moderate hearing loss.

Participants were asked to repeat 20 sentences they heard with background noise present — the AZBio sentence-in-noise task — under seven conditions: unaided, using a hearing aid, and using each of five PSAPs. The PSAPs included four of those with the most favorable acoustic properties sold at a large e-commerce retailer and one sold in a retail pharmacy. The hearing aid was one dispensed in a university audiology clinic.

The researchers controlled for order bias by randomly ordering sentence lists and devices.

Unaided mean hearing accuracy was 76.5%. With the hearing aid, speech understanding accuracy improved to 88.4%, for an absolute improvement difference of 11.9 percentage points (95% confidence interval [CI], 9.8 - 14.0 percentage points).

Three PSAPs improved hearing to within 5 percentage points of the hearing aid (Sound World SolutionsCS50+: accuracy, 87.4% [difference, 11.0 percentage points; 95% CI, 8.8 - 13.1 percentage points]; Soundhawk: accuracy, 86.7% [difference, 10.2 percentage points; 95% CI, 8.0 - 12.3 percentage points]; Etymotic BEAN: accuracy, 84.1% [difference, 7.7 percentage points; 95% CI, 5.5 - 9.8 percentage points]). A fourth PSAP improved hearing over baseline but provided a smaller gain in hearing accuracy (accuracy, 81.4%; difference, 4.9 percentage points; 95% CI, 2.8 - 7.0 percentage points).

One PSAP, the MSA 30X, actually made speech understanding worse than when participants used no device at all (accuracy, 65.3%; difference, −11.2 percentage points; 95% CI, —15.2 to —7.3 percentage points).

"The study was limited by a modest number of participants, sampled by convenience, who were tested in a controlled audiological setting under unilaterally aided conditions and with only a limited sample of currently available hearing technologies," the researchers explain. "Whether similar results would have been obtained with other devices or if the user self-programmed the device is unknown."

Few With Hearing Loss Use Hearing Aids

Hearing aids can only be purchased through a licensed professional in the United States and cost a mean of $4700 for two hearing aids; Medicare does not cover this expense.

Fewer than 20% of those with hearing loss report the use hearing aids, and making affordable PSAPs available over the counter would go a long way toward improving hearing for these individuals. Although these devices are "not specifically labeled for hearing loss treatment...some are technologically comparable with hearing aids and may be appropriate for mild to moderate hearing loss," the authors write.

One author reports being a consultant to Cochlear and receiving speaker honoraria from Amplifon. The remaining authors have disclosed no relevant financial relationships.

JAMA. Published online July 4, 2017. Article

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