Hear that? It’s the sound of dramatic upheaval in the audiology industry.

Last year, the President’s Council of Advisors on Science and Technology proposed making a new category for over-the-counter hearing devices. Hearing aids wouldn’t be sold at pharmacies, but personal sound amplification products would.

So what’s the difference? PSAPs are intended for people with mild-to-moderate hearing loss — people in their 30s to 50s who do not require hearing aids but want a little help when they’re in loud settings, such as restaurants.

The move, however, has hearing aid manufacturers and PSAP manufacturers sparring right now over whether or not the Food and Drug Administration should create and regulate an OTC hearing device category.

Hearing aid manufactures claim that people will turn to this new OTC segment and miss out on proper medical care. The Hearing Industries Association noted that not addressing hearing loss can have medical consequences, including a potential increase in dementia and a poor quality of life.

One U.S.-based manufacturer, Starkey, says that while PSAPs “may be less costly than most hearing aids, they can’t necessarily compete in regard to long-term health benefits, convenience, or features,” according to its website.

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On the other side, PSAP makers say their products aren’t trying to replace hearing aids. They just want to give people with mild-to-moderate, age-related hearing impairments “an assistive option.” PSAP makers cannot market the products for that population because they’re not regulated by the FDA, something that has made it hard to do business.

The HIA has opposed OTC hearing assistance device sales — while the Consumer Electronics Association and Hearing Loss Association of America support it but urge Americans to seek professional care before using the option.

Dr. Abram Bailey, an audiologist in Austin, Texas, and creator of the Hearing Tracker website, said he has “mixed feelings” about regulating OTC hearing amplifiers.

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“The FDA has a responsibility to educate consumers about the dangers of treating their own hearing loss, but I also think consumers should be allowed to make educated decisions that affect their personal health, even if there is a small risk they might get it wrong,” he said. Risk could be minimized, Bailey said, by mandating that product labels include a strong warning about the downsides of foregoing a medical assessment.

This month, the FDA held a workshop to hear all sides of the discussion. The agency is accepting comments through May 6, but hasn’t said when it would decide on the matter.

Sound Amplification
Dr. Drew Dundas, an audiologist in the San Francisco Bay area, said that about 90 percent of people with mild-to-moderate hearing issues could have better hearing, but choose not to because they think hearing aids are the only option. His inability to market his company to this consumer base doesn’t help raise awareness of PSAPs as an alternative, he said.

He created the Soundhawk PSAP, which runs for $399, for people who have less severe hearing issues and early-stage hearing loss. It is inserted into only one ear, much like a Bluetooth device. Users can fine-tune it through an app and make calls from it. It’s only used when needed — as opposed to hearing aids, which must be worn all the time.

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Dundas believes people should see doctors for hearing impairments. He’d also like to inform those who don’t need hearing aids about PSAPs, which are “not intended to compensate for impaired hearing.”

Dundas supports the addition of an OTC category because it “would make it easier for customers to determine what product would be most appropriate for them.”

He said there’s been talk of the top six hearing aid manufacturers producing their own PSAPs, but they do not want other manufacturers like Soundhawk to be able to do so. This is why they don’t want an OTC category, he explained.

“I don’t understand how we cover Viagra but we don’t cover hearing aids,” said one consumer. “Why Medicare doesn’t cover hearing aids is beyond me.”

Transparency and Consumer Focus Needed
The debate over OTC regulation has also raised questions about why many insurers do not cover hearing aids. Medicare only covers diagnostic hearing and balance exams ordered by a health care professional to see if medical treatment is necessary. It does not cover hearing exams, hearing aids, or hearing aid fitting exams.

Janice Lintz, a New York mother whose child has hearing loss issues, spoke at the recent FDA workshop to push for hearing aid insurance coverage. Lintz paid about $8,000 for one pair of hearing aids for her daughter and is baffled at why more consumers are not outraged.

“I don’t understand how we cover Viagra but we don’t cover hearing aids,” she said. “Why Medicare doesn’t cover hearing aids is beyond me.”

Lintz also wants to see the FDA clarify hearing aid and PSAP features by using generic terminology. This would help consumers better compare products — whether they allow direct PSAP sales or not.

“There is no ability to know what you’re purchasing, so you’re doing so blindly,” she said. Lintz said many people buy products that are bundled with extra services they don’t need. “There needs to be greater clarity, transparency, and oversight,” she said. “We’ve got to figure out to how disrupt this industry.”