In November 2013, the FDA published a draft guidance entitled, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.” The reason for the draft guidance was to distinguish the difference in the requirements for hearing aids and for Personal Sound Amplification Products (PSAPs).
Hearing Aids vs. Personal Sound Amplification Products
According to the draft guidance, “a hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing.” The devices are typically programmed based on an individual’s needs, and addresses hearing loss across a range of sound frequencies to improve speech intelligibility. “Additionally, hearing aids may be coupled acoustically or wirelessly to external electronic products such as televisions, MP3 players, and telephones. A hearing health professional (such as an audiologist or a hearing aid dispenser) is usually required to program and optimize the performance of hearing aids with these more complex features.”
In contrast, a PSAP is a wearable electronic product that works by amplifying sounds in certain environments. They are not intended to be used to compensate for hearing loss, but rather they simply magnify sounds for non-hearing impaired consumers when in certain atmospheres. Situations where PSAPs are typically used include: “hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations).”
Because they do not compensate for impaired hearing, PSAPs typically have less functionality than hearing aids, making them simpler devices. In addition, the draft guidance states that, in order to distinguish hearing aids from PSAPs, FDA relies on each product’s intended use to determine if it is a medical device or an electronic product. The distinction is established based on the product’s labelling or promotional materials. Furthermore, “labeling or promotional materials that make claims, or include language that suggests the use of a PSAP for hearing impaired consumers, establish an intended use for the electronic product as a medical device, which would therefore be subject to the regulatory requirements for a hearing aid.” Examples of labeling claims and language that could cause the product to be regulated as a medical device (vs. an electronic product) include:
- 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
- Wording to suggest that the product is an alternative to a hearing aid
Regulatory Requirements for Hearing Aids
For purposes of regulation (21 CFR 801.420), a hearing aid is “any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.” The regulations which are applicable to hearing aids apply to both air conduction and bone conduction devices, and include a variety of styles, such as behind-the-ear, in-the –canal, body worn, etc.
Hearing aids are not subject to the same regulation as cochlear implants, which are class III devices. Rather, “hearing aid devices, as distinguished from cochlear implants, may be classified as:
- Class I devices and exempt from premarket review and clearance before marketing (21 CFR 874.3300(b)(1))
- Class II devices, which require premarket review and clearance by FDA before marketing (21 CFR 874.3300(b)(2) and 21 CFR 874.3950)
- Class II devices that are exempt from premarket review and clearance before marketing (21 CFR 874.3305)
The draft guidance states that:
- “All hearing aids must comply with specific requirements regarding patient and professional labeling identified in 21 CFR 801.420,” including:
- “Specific labeling requirements for the hearing aid device itself as well as the content of the User Instructional Brochure that must be provided to potential recipients.”
- “All hearing aids must comply with the required conditions for sale, as stated in 21 CFR 801.421,” including:
- A prospective hearing aid user must provide a written statement from a licensed physician to the hearing aid dispenser, confirming that the prospective user has been medically evaluated within the past six months and is a candidate for a hearing aid.
- “Hearing aid dispensers must retain records of all medical evaluation statements and waivers for a period of three years after dispensing of the hearing aid.”
FDA established a these regulatory conditions for sale in order “to encourage prospective users to receive proper medical evaluation and treatment for treatable causes of hearing loss.”
Regulatory Requirements for PSAPs
The Radiation Control for Health and Safety Act of 1968 is the law under which electronic products that emit sonic vibrations are regulated by the FDA. Sound amplification equipment, such as PSAPs, are covered under the provisions of the act.
The draft guidance states that all defects and adverse events must be reported by PSAP manufacturers. PSAP manufacturers must also take all other measures described in 21 CFR Part 1003. In addition, per the draft guidance, “manufacturers of PSAPs must also comply with the requirements to repurchase, repair, or replace electronic products required under 21 CFR Part 1004.”
Any questions regarding PSAP requirements should be direct to the Branch Chief for the Magnetic Resonance and Electronic Products Branch at 301.796.6503.
Comment Period & Public Workshop
“Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 6, 2016.”
In addition, the Agency also published a notice of a public workshop entitled “Streamlining Regulations for Good Manufacturing Practices (GMPs) for Hearing Aids.” The workshop will be held on April 21, 2016, from 8:30am to 5 pm, and both written and electronic comments on the workshop can be submitted any time up until May 19, 2016.