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We Don't Need More Regulation on Over-the-Counter Hearing Devices

May 17, 2017 - 6:00am

For Floridians, personal sound amplification devices can boost sound that is too faint for most of us to hear. It can be used by consumers who want to temporarily heighten their hearing, including the use of headphones and equipment used to modestly boost the sound on telephones, listening devices and other audio amplification, and even to aid birdwatchers.

These are low-cost devices, available over-the-counter in stores like Walmart, Costco, Best Buy and elsewhere. They are typically a one-size-fits-all solution, and can be helpful for those with zero to modest hearing loss, including elderly consumers.

These devices are not substitutes for hearing aids, which can cost thousands of dollars, may include specific features and are typically personalized to fit patients’ ears. Hearing aids are medical devices recommended under the advisement of a licensed audiologist for patients with modest or severe hearing loss. Hearing aids are regulated by the Federal Drug Administration (FDA); personal amplification devices are regulated on the state level, not the FDA.

Now some members of Congress, led by Sen. Elizabeth Warren, want to change this. They are pushing a bill that would permit the FDA to regulate over-the-counter personal amplification devices as part of a new hearing aid category. The stated purpose of this regulatory move is to spur innovation, reduce consumer costs and improve consumer access to products -- but nothing can be further from the truth.

The bill -- “The Over the Counter Hearing Aid Act of 2017” -- brings nothing new in terms of consumer protections. While personal amplification devices are currently subject to state laws and regulations, the bill would preempt state oversight in favor of FDA guidance. By subjecting these devices to costly federal regulation, this legislation would benefit corporations that manufacture medical hearing aids and high-end sound devices. For example, Bose Corporation, headquartered in Senator Warren’s own state, could be one of the beneficiaries at the expense of consumer wallets.

The stated reasons for adding FDA regulation do not hold up to scrutiny. In fact, it’s hard to comprehend how giving federal bureaucrats more power to regulate market entry and approve new competitive devices would spur technological development. History is replete of examples where regulation impeded innovation. An examination of the public record shows that regulatory processes in DC can take a decade or more to resolve, including public hearings, notices in the Federal Register, notices of inquiry, notices of rulemaking, comment periods, reply periods, further notices, final notices and so on. Once in place, these regulations take decades to remove.

Simply put, DC bureaucracies can move a glacier’s pace, and not the fast pace of the innovation that we are now seeing in the electronics market. The bottom line is that everything that proponents of the bill want to regulate already exists, which means that passing this bill will do nothing to spur innovation.

In terms of FDA regulations reducing prices, that will never happen. As regulations increase, company compliance and surveillance costs will increase, which means more regulatory staff and more lawyers. The added bureaucracy will drain away dollars and increase company costs, all of which will be passed through to consumers in the form of higher prices. Lengthy proceedings create market uncertainty for investors and raise the cost of capital. If some products are developed and not approved by the FDA, these development costs will be added into the cost of other products, further driving up prices for Floridians.

When prices go up, and they will, consumer demand will be repressed. In other words, federal regulation will lead to higher consumer prices and reduced consumer access to affordable personal sound amplification devices -- exactly the opposite of what the bill promises to do. Higher prices and limited competition will benefit some big corporations, but it will not help consumers.

Consumers should be alarmed by some members in Congress trying to override state law. The result will ultimately give consumers less choice and higher prices. Floridians deserve better.
Steve Pociask is president of the American Consumer Institute, a nonprofit educational and research organization. For more information on the Institute, visit or follow us on Twitter @ConsumerPal.

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