Over-The-Counter Hearing Aids

by | Sep 6, 2022 | News

Americans Soon To Benefit From Affordable Over-the-Counter Hearing Aids

The Over-the-Counter Hearing Aid Act of 2017 recently gained full implementation. This result comes five years after Senator Elizabeth Warren (D-MA) first sponsored the bill.

A final rule by the U.S. Food and Drug Administration (FDA) intends to open the door to more affordable hearing aid treatments for Americans. Retailers may begin selling hearing aids over the counter as soon as October 17, 2022.

Executive Order Catalyzes Decisions To Allow Over-the-Counter Hearing Aids

Hearing aids are traditionally prescription devices for individuals with permanent hearing loss. The closest option Americans had to more accessible inexpensive hearing assistance were a few FDA-registered direct-to-consumer devices from electronics manufacturers, such as Bose. Many other brands sell personal sound amplification products (PSAPs) that boost sound without modifications to assist with distortion or hearing loss at distinct pitches.

The Biden-Harris Administration maintains affordable health care as one of its stated priorities. President Biden issued the Executive Order on Promoting Competition in the American Economy in the summer of 2021 to urge the FDA toward action on the 2017 bill mentioned above. Consumers will gain access to a new category of hearing devices for people that perceive mild to moderate hearing impairment.

A primary consideration for the guideline is safety. The FDA reviewed over 1,000 public comments and responded to the statements. The present statute incorporates changes from the proposed rule, including:

  • A safer insertion depth limit into a user’s ear canal
  • A lower maximum audio output to minimize the risk of over-amplification
  • Easier-to-understand wording on device labels 
  • A requirement that over-the-counter hearing aids have adjustable volume controls

Additionally, the FDA amended the rules for prescription hearing devices to align with the standards for models sold over the counter.

Americans Need Access to Affordable Hearing Care

Nearly 38 million American adults report some hearing difficulty, and studies indicate that hearing aids could benefit over 75% of those individuals. However, the cost of a hearing aid may range from $1,000 to over $4,000.

Recent statistics show that the real median income in the U.S. recently decreased by 3%. This fact demonstrates that purchasing a set of hearing aids could create a financial burden, particularly on low-income households. Regrettably, reports also confirm that people with unaided hearing loss average $20,000 less in yearly income than their counterparts who receive hearing medical devices.

The newly-formed distinct category for over-the-counter aids should promote more competition among electronics companies that manufacture hearing aids. Experts believe a more open market will decrease costs and accelerate innovation in the market.

The Regulatory Requirements for Hearing Aid Devices and PSAPs is the final guidance that further distinguishes hearing aids from PSAPs. Consumers must understand that PSAPs are simply amplification products comparable to Bluetooth headsets or stereo speakers, while a hearing aid is a medical device.

Consumers Have Help To Understand Over-the-Counter Options

This long-awaited action permits access to new choices for sufferers of hearing impairment. However, a flood of options may confuse a person desiring an effective and affordable treatment.

If you or someone you love is having issues with hearing, diagnosis and treatment is available. Did you know we have free hearing aid consultations in-person or via zoom? Contact us today to learn more about our services or to make an appointment:

Call or text: (626) 734-6555

Email us at: appointments@hearcenter.org 

Chat us: https://direct.lc.chat/13342371/

Also, for more information about our Audiological Evaluations (hearing test) please visit our webpage: https://www.hearcenter.org/services/audiology/