Guideline based on FDA’s informations for the Over-The-Counter Market.
What are hearing aids ?
Hearing aids are sound-amplifying devices designed to aid people who have a hearing impairment. They are medical devices regulated by the FDA and delivered by a hearing aid provider or an audiologist. Most hearing aids share several similar electronic components, including a microphone that picks up sound; amplifier circuitry that makes the sound louder; a miniature loudspeaker (receiver) that delivers the amplified sound into the ear canal; and batteries that power the electronic parts. Hearing aids differ by design, the technology used to achieve amplification (i.e., analog vs. digital) and special features. Some hearing aids also have earmolds or earpieces to direct the flow of sound into the ear and enhance sound quality. The selection of hearing aids is based on the type and severity of hearing loss, listening needs, and lifestyle.
What are Over-The-Counter hearing aids?
A new class of over-the-counter (OTC) hearing devices is coming. The OTC Hearing Aid Act of 2017 that was passed by Congress and signed by President Trump on August 18, 2017 requires the FDA to create and regulate a category of OTC hearing aids for adults with “perceived” mild-to-moderate hearing loss and to ensure the devices meet the same high standards for safety, consumer labeling, and manufacturing protection that all other medical devices must meet. How should the US Food and Drug Administration (FDA) define and regulate these devices? A consensus published August 14, 2018 by four national hearing care professional organizations recommends the devices be called “Self-fit OTC Hearing Devices” and be intended for mild-to-moderate hearing losses of 26-55 dB HL (26 max HFA-FOG/110 dB max output), offer input compression and volume controls, contain clear and easy-to-understand labeling both on the inside and outside of the packaging, and require at last one FDA 510(k) filing to ensure the basic safety and efficacy of the device. The 35-page consensus statement, “Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness,” was developed by a Working Group of the American Academy of Audiology (AAA), Academy of Doctors of Audiology (ADA), American Speech-Language-Hearing Association (ASHA), and International Hearing Society (IHS). The consensus paper is divided into five key recommendations:
- Establish product requirements appropriate for OTC hearing devices targeting mild‐to‐moderate adult hearing impairment.
- Out-of-the-box labeling with “Red Flag” warnings and a strong recommendation to consult with a licensed hearing care professional.
- Inside-of-the-box labeling.
- Define new OTC category as “Self-fit OTC Hearing Devices” and use risk class requirements for safety and effectiveness.
- Adequate provisions for consumer protection and oversight by Federal Trade Commission (FTC).
What are Self-fitting air-conduction hearing aid?
According to the FDA’s definition, the self-fitting air-conduction hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. The new Class II self-fitting classification within hearing aids should not be confused with the still-to-come Over-the-Counter (OTC) Hearing Aid classification that FDA is developing witch is designed to provide better affordability and accessibility for adults with perceived mild-to-moderate hearing loss, and give them access to OTC hearing aids without being seen by a hearing care professional. In contrast, the new Class II self-fitting device—the Bose Hearing Aid is the first example—is a hearing aid within the “traditional” Class I (for non-wireless air conduction hearing aids) and Class II (for wireless air-conduction and bone conduction hearing aids) medical device categories as established by FDA. However, the new classification includes a fairly extensive list of “special controls” intended to address risks to “health and mitigation measures.”
- Clinical data must evaluate the effectiveness of the self-fitting strategy.
- Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.
- Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
- Software verification, validation, and hazard analysis must be performed.
- If the device incorporates wireless technology: (A) Performance testing should validate safety of exposure to non-ionizing radiation; (B) Performance data should validate wireless technology functions; and (C) Labeling should specify instructions, warnings, and information relating to wireless technology and human exposure to non-ionizing radiation.
- Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.
- Patient labeling must include the following: (A) Information on how a patient can self-identify as a candidate for the device; (B) Information about when to seek professional help; (C) A warning about using hearing protection in loud environments; (D) A warning about staying alert to sounds around you; (E) Technical information about the device, including information about electromagnetic compatibility; and (F) Information on how to correctly use and maintain the device.
What are Personal Sound Amplification Products?
Personal Sound Amplification Products (PSAPs) are intended to amplify environmental sound for non-hearing impaired consumers. They are not intended to compensate for hearing impairment. Examples of situations in which PSAPs typically are 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, performances). 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 Food, Drug, and Cosmetic Act. As such, there is no regulatory classification, product code, or definition for these products. Furthermore, there are no requirements for registration of manufacturers and listing of these products with the FDA. However, PSAPs are subject to applicable provisions of the Radiation Control for Health and Safety Act of 1968, under which the FDA regulates electronic products that emit sonic vibrations, such as sound amplification equipment. (See also 21 CFR 1000.15.) Manufacturers of PSAPs must report defects and adverse events and take other measures described in 21 CFR Part 1003. Manufacturers of PSAPs must also comply with the requirements to repurchase, repair, or replace electronic products required under 21 CFR Part 1004.
What are FrenchEar FE1+ Universal Acoustic Solution?
The first version of the FE1+ universal acoustic solution is not a medical device. It is therefore not a Hearing Aid (HA) for which an FDA 501 (k) marketing authorization is required. As the regulation on Over-The-Counter Hearing Aid was not stopped prior to August 2020, the first version of the FE1+ is therefore classified as a Personal Sound Amplification Product (PSAP). However, FrenchEar is developing a future version of its PSAP that will become an OTC Hearing Aid particularly suitable for mild to moderate deafness.
Citations for this article :
https://www.audiology.org/sites/default/files/publications/resources/20180130_AuD_Guide_OTC.pdf
