But Wait…There’s More! Part 2 – Labeling

“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.


This is the second of three posts that summarizes the Hearing Industries Association’s (HIA) recommendations to the Food and Drug Administration’s (FDA) Office of Device Evaluation, the office primarily responsible for promulgating the OTC hearing aid rules following the passage and signing of the FDA Reauthorization Act into law on August 18th. As part of this law, FDA is directed to create and regulate a new category of hearing aids that can be sold over-the-counter (OTC) to individuals with mild to moderate hearing loss.

HIA’s recommendations are in response to a FDA draft document unveiled and discussed at the June 9th, 2017 National Academies of Sciences, Engineering and Medicine (NASEM) stakeholders meeting.  My first post focused on HIA’s recommendations concerning OTC regulatory overview provisions. This post will focus on HIA’s OTC labeling recommendations. In the interest of full disclosure, I am a consultant to the HIA and contributed to the Association’s letter to the FDA.


What’s Labeled and What’s Muffled


The labeling section described in FDA’s draft document provides four specific use-cases describing those who might benefit from an OTC hearing aid to include those who experience:

  1. Muffling of speech and other sounds;
  2. Trouble hearing in groups or noisy places, or when you cannot see who is talking;
  3. Asking others to speak more slowly, clearly, and loudly, or repeat what they said; or
  4. Needing to turn up the volume of the TV, radio or music

HIA objected to the language describing use-cases 1 and 3; specifically, “muffled speech” may be an indicator of more clinically significant hearing difficulties that may require medical intervention. Moreover, the word “muffled” is subjective and means different things to different people. When speech is described as distorted or muffled, it indicates that speech intelligibility is compromised, suggesting the possibility of more severe impairment.

In terms of use-case 3, suggesting that OTCs are appropriate for anyone asking others to speak more slowly and loudly may inadvertently result in individuals using OTC hearing aids who struggle with auditory processing problems.


More Labeling, Less Muffling


HIA recommended adding additional labeling language; specifically,

“A person with a mild to moderate hearing loss will generally experience problems understanding quiet conversations and soft environmental sounds, especially in noisy surroundings. If you have difficulty hearing or understanding normal conversational speech you should consult with a hearing professional before purchasing this device.” HIA also suggested that the outer packaging explicitly state, “OTC hearing aids are intended for use only by those with 26 to 40 decibels of hearing loss. Before buying an OTC hearing aid you should have your hearing tested. If you have more than 40 decibels of hearing loss you should not use OTC hearing aids and you should consult a hearing professional about your hearing loss.”

This language should help ensure that, for the intended use population, the benefit will outweigh the risk.

HIA also suggested that specific information be included prominently on the outer packaging of the device including:

“If you have any of the following conditions [as discussed below], do not buy this product. You should see a licensed hearing healthcare professional before proceeding,” and “If you have hearing loss greater than MILD OR MODERATE, you should consult a hearing professional.”

Furthermore, the labeling on the outer package should explicitly state that

“OTC hearing aids are for adult use only.”  

Any warranty or guarantee should be prominently displayed on the outer packaging, as consumers need to know their options before they buy a product.

The following language should also appear on the box:

“Consumers who work with hearing care providers and consumers who are trained in the use of properly prescribed and fitted hearing devices can expect better results than those who use off-the-shelf (also referred to as “OTC”) products”

That language is consistent with conclusion 5-2 of the  NASEM 2017 report on “The Promise of Assistive Technology to Enhance Activity and Work Participation.”


Don’t Forget Those Red Flags of Yore


Finally, HIA supports the FDA’s draft document labeling language concerning “red flag” conditions (to be placed on the outside of the box) to include:

  • Fluid, pus, or blood coming out of the ear within the previous 6 months;
  • Pain or discomfort in the ear;
  • History of excessive ear wax or suspicion that something is in the ear canal;
  • Episodic vertigo (severe dizziness) associated with hearing loss;
  • Sudden, quickly worsening, or fluctuating hearing loss within the previous 6 months; and
  • Hearing loss or tinnitus (ringing) only in one ear or a noticeable difference in hearing between ears.

HIA suggested the addition of one additional red flag condition:

  • Visible deformity of the ear.


Think Inside the Box, Too


Other information that is not critical to the decision to purchase the device but is nevertheless critical to safe and effective use should appear on the labeling within the box.

HIA suggested that some of the information in the FDA draft document meant for the package labeling is more appropriate in the Instructions for Use (IFU) brochure including the following statement:

“If you try this device and continue to struggle with or remain concerned about your hearing, you should seek a consultation with a hearing healthcare professional.”

Notifications that the product may need adjustment to help a consumer hear better, in addition to instructions for adjustment and fit, should be included in the IFU. Additionally, a statement explaining the value of a hearing test prior to using this product should be part of the IFU as well as information concerning the servicing the OTC, potential conditions that may harm the hearing aid, side effects of use of the hearing aid, and instructions on how to get support from the manufacturer.

The brochure must be clear that infrequent use of the device may compromise benefit and that a hearing aid will not restore normal hearing or prevent or improve hearing impairment resulting from medical conditions. All of this information must be written at a level and in a manner that consumers can understand. The manufacturer should be required to conduct studies demonstrating that all written material is readable and understandable, as is required for other OTC products.


OTC Current Practices


HIA’s recommendations are consistent with current practices. There are many OTC devices on the market which manage to incorporate intended use, warnings, and caution statements on the outer packaging. OTC products, including blood glucose monitors, heat therapy patches, dental night-guards, and ear syringes suggest consulting physicians or dentists in the presence of certain “red flags.” Even a simple ThermaCare Heat Wrap  lists several instances in which the product should not be used, under what conditions a doctor should be consulted prior to use, and several separate and detailed warnings. In fact, OTC medical device products routinely include warnings and safety precautions, refer consumers to the full IFU, detail the contents of the box, and include a discussion of product features.

Next time: HIA’s recommendations concerning specifications and standards for OTC hearing aids.


Harvey Abrams PhD

Harvey Abrams, PhD, is a consulting research audiologist in the hearing aid industry. Dr. Abrams has served in various clinical, research, and administrative capacities in the industry, the Department of Veterans Affairs and the Department of Defense. Dr. Abrams received his master’s and doctoral degrees from the University of Florida. His research has focused on treatment efficacy and improved quality of life associated with audiologic intervention. He has authored and co-authored several recent papers and book chapters and frequently lectures on post-fitting audiologic rehabilitation, outcome measures, health-related quality of life, and evidence-based audiologic practice.  Dr. Abrams can be reached at hbabrams@gmail.com

Images from Ross Land/Getty and askideas

About Holly Hosford-Dunn

Holly Hosford-Dunn, PhD, graduated with a BA and MA in Communication Disorders from New Mexico State, completed a PhD in Hearing Sciences at Stanford, and did post-docs at Max Planck Institute (Germany) and Eaton-Peabody Auditory Physiology Lab (Boston). Post-education, she directed the Stanford University Audiology Clinic; developed multi-office private practices in Arizona; authored/edited numerous text books, chapters, journals, and articles; and taught Marketing, Practice Management, Hearing Science, Auditory Electrophysiology, and Amplification in a variety of academic settings.