Skip to content
  • About
  • Contact
  • Contribute
  • Book
  • Careers
  • Podcast
  • Recommended
  • Speaking
  • All
  • Physician
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • Video
    • All
    • Physician
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • Video
    • About
    • Contact
    • Contribute
    • Book
    • Careers
    • Podcast
    • Recommended
    • Speaking

Should the government regulate hearing aids as consumer electronic products?

Shari A. Hicks, CPhT
Policy
September 21, 2019
119 Shares
Share
Tweet
Share

As a pharmacy technician, I watched countless individuals speak with a pharmacist about how different drug therapies work, and what they should know before taking any pharmaceuticals.

But I also have a hearing loss, and as a patient myself, I am struck by how confusing it is for consumers to find the right treatment.

Hearing loss is a medical condition that affects nearly one-third of adults between 65 and 75, and half of those 75 and older. But only about 30 percent of those who could benefit from hearing aids have ever tried them. This is a troubling statistic.

Two years ago, Congress passed the Over-the-Counter-Hearing-Aid Act of 2017 that mandates the Food and Drug Administration (FDA) create a new category of hearing aids for mild-to-moderate hearing losses. This law was designed to increase consumer access by making hearing solutions available over-the-counter without the guidance of a licensed professional.

The FDA is determining how to regulate this new category of consumer products and how to expand access to hearing devices, while fulfilling its Congressional mandate to ensure they are safe, effective, and used correctly.

Currently, there are two main categories of products designed to amplify in-ear sounds.

Hearing aids are medical devices intended to correct hearing loss and are already regulated by the FDA.  Currently, hearing aids are dispensed only after a hearing care professional performs testing to determine the level and type of hearing loss. If appropriate as treatment, a device is then recommended, and programmed to the precise needs of the individual hearing experience.

Personal sound amplification products or PSAPs, on the other hand, are designed to increase environmental sounds for non-hearing-impaired consumers and are not regulated as medical devices. PSAPs amplify all nearby sounds, which is useful for certain specific activities, such as detecting animal sounds in the wild.

The FDA has acknowledged that PSAPs are not a replacement for hearing aids, as the characteristics that make for a good PSAP are very different than those in a hearing aid designed to correct a medical condition.

While the FDA has not yet revealed specifications for the new OTC category of hearing aids, actions by the agency last fall related to the marketing of ‘self-fitting’ hearing aids suggest it may be leaning toward regulating the OTC hearing aids based on a “consumer electronics” standard and not on a standard for medical devices.

If OTC hearing aids are regulated as consumer electronics products, these devices will be allowed to produce a maximum output of 120 decibels. This is as loud as a live rock concert or aircraft at take-off. This can be dangerous – not only could it increase the consumer’s hearing loss, but it could induce pain and ear injury.

This is neither safe nor effective.

Both the World Health Organization and the U.S. Center for Disease Control recommendations state that sounds as high as 120 decibels can be safely listened to for only seconds per day. Consistently, hearing care professionals have made recommendations more in line with safe and effective standards for medical devices that include a maximum output at 110 decibels and a limit on the gain (or amplification) that the devices can produce.

Over-the-counter hearing aids could benefit many people who suffer from mild to moderate hearing loss. Making them accessible through popular retail outlets is a good idea that promotes consumer choice. But the FDA has the responsibility to ensure consumers are protected against misuse of products designed for a different purpose entirely.

Shari A. Hicks is a pharmacy technician.

Image credit: Shutterstock.com

Prev

The orthopedic objectification of women

September 21, 2019 Kevin 10
…
Next

An American doctor in Rome

September 21, 2019 Kevin 6
…

Tagged as: Otolaryngology

Post navigation

< Previous Post
The orthopedic objectification of women
Next Post >
An American doctor in Rome

Related Posts

  • HIV/AIDS vaccine underscores need for better health access

    Alyson O’Daniel, PhD
  • People who take opioids are the AIDS patients of today

    Heather Finlay-Morreale, MD
  • Unapproved CBD products may not be as safe as they seem

    Kenneth Finn, MD
  • It’s time for presidential candidates to debate the safety of pharmaceutical products

    Steven Reznick, MD
  • It’s time to change how we regulate methadone

    Paul Joudrey, MD, MPH
  • What matters in an optimal consumer health care market

    Richard Reece, MD

More in Policy

  • Unveiling the intricate link between housing costs and health care

    Harvey Castro, MD, MBA
  • Uncovering the truth about racial health inequities in America: a book review

    John Paul Mikhaiel, MD
  • Why affirmative action is crucial for health equity and social justice in medicine

    Katrina Gipson, MD, MPH
  • The untold story of Hispanic/Latino health: Why subgroup data matters

    Matthew B. Alonso
  • Unmasking the brutal reality of gun violence in America: a call to action for unity and meaningful change

    Osmund Agbo, MD
  • Family physicians unite at the U.S. Capitol, seeking congressional support for Medicare reform and health care transformation

    Tochi Iroku-Malize, MD, MPH, MBA, Sterling N. Ransone, Jr., MD, and Steven P. Furr, MD
  • Most Popular

  • Past Week

    • The power of coaching for physicians: transforming thoughts, changing lives

      Kim Downey, PT | Conditions
    • The hidden factor in physician burnout: How the climate crisis is contributing to the erosion of well-being

      Elizabeth Cerceo, MD | Physician
    • Why affirmative action is crucial for health equity and social justice in medicine

      Katrina Gipson, MD, MPH | Policy
    • Unlocking the secrets of cancer conferences: an end-of-life counselor’s journey among pharmaceutical giants

      Althea Halchuck, EJD | Conditions
    • Why doctors aren’t to blame for the U.S. opioid crisis [PODCAST]

      The Podcast by KevinMD | Podcast
    • Nose-brain connection: The surprising link between allergies and mental health revealed

      Kara Wada, MD | Conditions
  • Past 6 Months

    • It’s time to replace the 0 to 10 pain intensity scale with a better measure

      Mark Sullivan, MD and Jane Ballantyne, MD | Conditions
    • “Is your surgeon really skilled? The hidden threat to public safety in medicine.

      Gene Uzawa Dorio, MD | Physician
    • Breaking point: the 5 reasons American doctors are dreaming of walking away from medicine

      Amol Shrikhande, MD | Physician
    • Revolutionize your practice: the value-based care model that reduces physician burnout

      Chandravadan Patel, MD | Physician
    • Unveiling the hidden damage: the secretive world of medical boards

      Alan Lindemann, MD | Physician
    • Breaking the cycle of racism in health care: a call for anti-racist action

      Tomi Mitchell, MD | Policy
  • Recent Posts

    • Unconventional health care, flawed studies, and biases: Navigating the complexities for optimal well-being

      Kara Wada, MD | Physician
    • Urgent innovation needed to address growing mental health crisis among children and families

      Monika Roots, MD | Conditions
    • The importance of listening in health care: a mother’s journey advocating for children with chronic Lyme disease

      Cheryl Lazarus | Conditions
    • Medical errors and the power of apologies [PODCAST]

      The Podcast by KevinMD | Podcast
    • Finding your ideal work-life balance: tips for prioritizing personal life and achieving professional success

      Zahid Awan, MD | Physician
    • Boxing legends Tyson and Foreman: powerful lessons for a resilient and evolving health care future

      Harvey Castro, MD, MBA | Physician

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

View 2 Comments >

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

CME Spotlights

From MedPage Today

Latest News

  • JAK Inhibitor Shows Promise in Severe Type of Sclerosis
  • Adaptive RT Fails to Relieve Dry Mouth in Head and Neck Cancer
  • FDA OKs Olaparib-Abiraterone for Metastatic Prostate Cancer
  • Sleep-Disordered Breathing Tied to Brain Volumes in Amyloid-Positive Older Adults
  • Trial Shows RA Can Be Stopped at Preclinical Stage

Meeting Coverage

  • Trial Shows RA Can Be Stopped at Preclinical Stage
  • Tenapanor Improves Abdominal Symptoms in Patients With IBS-C
  • Benefits Found for Hand OA Drug Treatments
  • MRI-Based Screening May Detect Prostate Cancer Earlier
  • New Model Aims to Study Intestinal Fibrosis in Crohn's Disease
  • Most Popular

  • Past Week

    • The power of coaching for physicians: transforming thoughts, changing lives

      Kim Downey, PT | Conditions
    • The hidden factor in physician burnout: How the climate crisis is contributing to the erosion of well-being

      Elizabeth Cerceo, MD | Physician
    • Why affirmative action is crucial for health equity and social justice in medicine

      Katrina Gipson, MD, MPH | Policy
    • Unlocking the secrets of cancer conferences: an end-of-life counselor’s journey among pharmaceutical giants

      Althea Halchuck, EJD | Conditions
    • Why doctors aren’t to blame for the U.S. opioid crisis [PODCAST]

      The Podcast by KevinMD | Podcast
    • Nose-brain connection: The surprising link between allergies and mental health revealed

      Kara Wada, MD | Conditions
  • Past 6 Months

    • It’s time to replace the 0 to 10 pain intensity scale with a better measure

      Mark Sullivan, MD and Jane Ballantyne, MD | Conditions
    • “Is your surgeon really skilled? The hidden threat to public safety in medicine.

      Gene Uzawa Dorio, MD | Physician
    • Breaking point: the 5 reasons American doctors are dreaming of walking away from medicine

      Amol Shrikhande, MD | Physician
    • Revolutionize your practice: the value-based care model that reduces physician burnout

      Chandravadan Patel, MD | Physician
    • Unveiling the hidden damage: the secretive world of medical boards

      Alan Lindemann, MD | Physician
    • Breaking the cycle of racism in health care: a call for anti-racist action

      Tomi Mitchell, MD | Policy
  • Recent Posts

    • Unconventional health care, flawed studies, and biases: Navigating the complexities for optimal well-being

      Kara Wada, MD | Physician
    • Urgent innovation needed to address growing mental health crisis among children and families

      Monika Roots, MD | Conditions
    • The importance of listening in health care: a mother’s journey advocating for children with chronic Lyme disease

      Cheryl Lazarus | Conditions
    • Medical errors and the power of apologies [PODCAST]

      The Podcast by KevinMD | Podcast
    • Finding your ideal work-life balance: tips for prioritizing personal life and achieving professional success

      Zahid Awan, MD | Physician
    • Boxing legends Tyson and Foreman: powerful lessons for a resilient and evolving health care future

      Harvey Castro, MD, MBA | Physician

MedPage Today Professional

An Everyday Health Property Medpage Today
  • Terms of Use | Disclaimer
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

Should the government regulate hearing aids as consumer electronic products?
2 comments

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...