The US Food and Drug Administration (FDA) has concluded that the Bose Hearing Aid should be classified as a Class II device under the generic name “self-fitting air-conduction hearing aid,” according to an October 5 letter from FDA Deputy Director of Engineering and Science Review Angela C. Krueger. Accordingly, Bose is free to market the device immediately subject to general provisions and special controls required by FDA (see below). The letter followed a May 11, 2018 De Novo filing by Bose requesting classification of the Bose Hearing Aid as a self-fitting hearing aid.
According to the letter, the FDA’s definition of the new category is:
Self-fitting air-conduction hearing aid. A 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.
However, the new classification includes a fairly extensive list of “special controls” intended to address risks to “health and mitigation measures.” Many of these special controls were advocated by hearing care professional organizations in a recent consensus statement (see October Hearing Review, pgs 8-9), and later endorsed by the Hearing Industries Association (HIA). These special controls include:
- 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.
Currently, the FDA can exempt Class II devices from premarket notification (510[k]) requirements, but it has determined premarket notification is necessary for this type of device. Therefore, subsequent applications for a self-fitting hearing aid will be required to contain premarket notification information. More details about these requirements will be contained in a summary Special Controls document expected from FDA within about a month, which will also contain the clinical study on which Bose’s De Novo application was based.
The letter also reminded Bose the De Novo request doesn’t mean that FDA has determined that the device complies with other Agency requirements, which include labeling, medical device reporting, good manufacturing practices (GMPs), and electronic radiation control provisions.
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. The OTC Hearing Aid Act was passed by Congress and signed into law by President Trump in August 2017 as part of the FDA Reauthorization Act of 2017 (FDARA). It 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 being 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.
For more information on the Bose Hearing Aid, see the recent Hearing Review blog “Gleanings from Bose Leaders about the Bose Hearing Aid“.