The US Food and Drug Administration (FDA) released on November 7 a draft Guidance Document that, when finalized, is designed to further clarify the regulatory distinctions between hearing aids and personal sound amplification products (PSAPs). The original language defining PSAPs by the Agency was issued in its February 2009 Guidance for the Industry and FDA Staff.
The latest Guidance document on hearing aids and PSAPs does not depart significantly from the definitions previously set forth by the FDA in 2009. The Agency regulates hearing aids as medical devices, while PSAPs are designed to enhance normal hearing rather than to address hearing loss and are therefore not subject to FDA regulation. However, the Agency in its original 2009 Guidance banned the marketing of PSAPs as hearing aids, with the intent to prohibit PSAP manufacturers from targeting hearing-impaired individuals.
It would appear that the latest Guidance Document takes a tougher stance on those PSAP manufacturers that market their products to hearing-impaired consumers and use subtle (and not so subtle) references to their hearing loss. The Draft Guidance emphasizes that “FDA relies on the intended use of each product to determine whether it is a medical device or an electronic product.” The Agency lists a variety of potential claims and language that would establish an intended use as a medical device such as:
· A description of the types and severity of hearing loss;
· A description of listening situations that are typically associated with and indicative of hearing loss; and
· Wording to suggest that the product is an alternative to a hearing aid.
Specifically, the Guidance document defines hearing aids and PSAPs as:
Hearing aids. Hearing aids are still defined by FDA as wearable sound amplification devices intended to compensate for a hearing loss, covering both air and bone conduction and essentially all styles of hearing aids (eg, BTEs, RICs, ITEs, CICs, etc). The Draft Guidance document describes the current three categories of Class I and Class II devices relative to premarket review and clearance prior to marketing the products:
1) Class I devices which are all exempt from FDA premarket review and clearance;
2) Class II devices that are exempt from premarket review and clearance; and
3) Class II devices that require premarket review and clearance.
The regulatory definition for generic hearing aids (air and bone conduction devices) falls under #1 above; wireless air-conduction hearing aids fall under #2 above, and have various special controls for items such as electromagnetic compatibility, design, labeling, etc; and systems like transcutaneous air conduction hearing aid systems fall into #3 above.
The document describes how all hearing aids are subject to various FDA requirements, such as the currently established patient and professional labeling requirements (eg, provision of the User Instructional Brochure), the physicians’ statement of medical evaluation or waiver, and standard conditions of sale for dispensing professionals (eg, retaining records of medical evaluation statements and waivers for a 3-year period following the dispensing of an aid).
PSAPs. The Draft Guidance document states that “PSAPs are intended to amplify environmental sound for non-hearing impaired consumers” and are not subject to FDA regulation. However, the document also goes on to say:
“Examples of listening situations that are typically associated with and indicative of hearing loss include: difficulty listening to another person nearby, difficulty understanding conversations in crowded rooms, difficulty understanding movie dialogue in a theater, difficulty listening to lectures in an otherwise quiet room, difficulty hearing the phone or doorbell ring, or difficulty listening in situations in which environmental noise might interfere with speech intelligibility. Products making these or similar claims should not be considered PSAPs. In addition, products that are sold as an “over the counter” alternative or substitute for a hearing aid should not be considered PSAPs. Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the FD&C Act. As such, there is no regulatory classification, product code, or definition for these products. Furthermore, there are no requirements for registration of manufacturers or listing of these products with FDA.”
PSAPs are not subject to the same regulations as hearing aids. However, PSAPs are subject to provisions in the 1968 Radiation Control for Health and Safety Act, and must report defects and adverse events and take other measures prescribed. They must also comply with requirements for repurchase, repair, or replacement of electronic products as set forth by 21 CFR Parts 1000, 1003, and 1004.
Comment period. The document states that the Draft Guidance contains non-binding recommendations, but, when finalized, will represent its current thinking on the topic. Written comments and suggestions may be submitted to the Agency within 90 days of the announcement of the document in the Federal Registry (published November 7).
FDA also publishes new Consumer Update. On November 6, the day before issuing the above described Draft Guidance document, FDA issued a Consumer Update titled “Hearing Loss Signals Need for Diagnosis” about the perils of delaying the diagnosis of a treatable or serious ear condition. The document covers why some hearing losses could be life threatening, the difference between hearing aids and PSAPs, and facts that consumers should be aware of before purchasing a hearing aid, including the difference between an audiologist and hearing aid dispenser, and other advice for seeking hearing help.