INSURANCE: Cheaper Hearing Aids at Last?

For many years hearing aids have been the primary choice of both regulators and audiologists to help offset a hearing loss. But a new gadget has surfaced, forcing both the U.S. Food and Drug Administration (FDA) and industry professionals to re-evaluate their stance. At the annual AudiologyNOW! Conference, held a few weeks ago in Phoenix, Ariz., thederegulation of the hearing-aid industry was a hot topic.

Key players in the consumer electronics industry have developed personal sound amplification products (PSAPs) that not only rival standard hearing aids but also sell for a fraction of the price. Plus, evaluation from an audiologist is not necessary. Sounds appealing, but industry professionals aren’t buying it.

Why the Resistance?

It’s all a matter of professional expertise, but consumers shouldn’t be taking matters into their own hands by diagnosing and treating their own hearing loss. At least that’s how audiologists are feeling about the proposed deregulation. In fact, “the law requires that patients intending to buy hearing aids must either have a medical exam or sign a waiver saying they do not want a medical exam to rule out a medical reason for their hearing loss before buying hearing aids,” says the FDA.

The FDA also urges consumers to see a licensed professional who specializes in ear diseases. But if consumers bypass a professional evaluation and simply bandage the problem with PSAPs, they could very well face bigger issues with their ears down the road.

PSAPs vs. Hearing Aids

There are three distinct differences between PSAPs and hearing aids:

FDA Classification – “[The] FDA does not consider sound amplifiers to be medical devices when labeled for recreational or other use by individuals with normal hearing,” notes the FDA. Simply put, the FDA does not classify PSAPs as medical devices to treat hearing loss. Its reasoning? PSAPs “increase environmental sounds for non-hearing impaired consumers. [They] are not intended to amplify speech or environmental sound for individuals with impaired hearing or to compensate for hearing impairment,” its website adds.
Safety Issues – You must also consider the dangers associated with both hearing aids and PSAPs. The FDA urges consumers to seek the assistance of a licensed professional to ensure that their hearing aid is fitted properly and amplifies sound at a level that is appropriate for their hearing loss. Otherwise, additional damage to your hearing could result. Because a professional evaluation by an audiologist is not necessary to purchase a PSAP, there is no way to hedge against the risk of damage from excessive sound amplification.
Lower Prices – PSAPs also come at much lower prices than hearing aids. These devices are sold for anywhere between $100 and $600, while hearing aids can cost up to $3,000, notes the Wall Street Journal. Unfortunately, Medicare and most private insurance providers do not cover the cost of hearing aids. However, free hearing aids and batteries are available to eligible veterans, according to the U.S. Department of Veteran Affairs.

The Case for Deregulation

The hearing-aid industry is perceived by some outside it as “too costly and cumbersome, [which is] hindering access to devices vital for the older legions of older Americans,” notes The New York Times. Not only are the folks in Washington on board with possibly deregulating the industry; Dr. William H. Maisel, acting director of the Office of Device Evaluation at the FDA, told the Times that his organization is also “willing to evolve and change, if that is appropriate.”

Perhaps industry outsiders, White House advisors and the FDA have valid points. While the hearing-aid market is clearly a major financial opportunity for consumer electronic powerhouses, customers will also benefit from the steep price reduction, finally gaining access to a product that can mitigate their hearing loss. (For more, see Pharmaceutical Sector: Does the FDA Help or Harm?)

Are PSAPs the Hearing Aids of the Future?

That’s always a possibility, but as technology evolves, hearing-aid manufacturers will have to adjust, or they could experience a decline in their profit margins. Furthermore, PSAP sales could easily trump those of hearing aids if the FDA moves forward with setting standards to mitigate the underlying risks associated with these devices.

The Bottom Line

PSAPs are giving hearing-aid manufacturers a run for their money, and some audiologists have already begun recommending these products to patients with mild hearing loss. If the FDA steps in and loosens regulations, it could mean more access to hearing-loss products for consumers, as hearing aids are not covered by Medicare and most private insurance providers. (For more, see What Does Medicare Cover?) Needless to say, consumer electronic manufacturers could see a tremendous boost to their bottom line, as well