The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to the regulatory requirements for hearing aid devices and personal sound amplification products. Once finalized, the document will be intended to provide medical device manufacturers and other parties involved with additional clarifications regarding the applicable requirements set forth by the current legislation, as well as recommendations to be considered to achieve and sustain compliance thereto. At the same time, it is important to mention that FDA guidance documents are non-binding, so an alternative approach could be applied, provided such an approach complies with the respective requirements and has been agreed with the authority in advance. 

Regulatory Background 

The document is intended to provide additional details regarding the regulatory requirements for hearing aids and personal sound amplification products (PSAPs) as set forth by the Federal Food, Drug, and Cosmetic (FD&C) Act. First of all, the authority describes the difference between these devices. In particular, it is stated that despite both devices being used to impact the ability to hear, the intended use of these products is different. Hence, the regulatory requirements these devices are subject to will be different as well. In this regard, the authority states that unlike hearing aids which are intended to aid a person with or compensate for hearing impairment, PSAPs are not intended to diagnose, treat, cure, mitigate or prevent disease and are not intended to affect the structure or function of the body. Consequently, such products are falling outside the scope of “medical devices” as outlined in the appropriate definition contained in the FD&C Act. 

The Agency acknowledges certain confusion resulting from the lack of legal clarity in terms of distinguishing these two types of products. Thus, to assist medical device manufacturers and other parties involved in distinguishing these products and determining the applicable regulatory framework, the present guidance describes in detail each type of product and regulatory requirements it should be subject to.


Scope and Definitions 

According to the applicable legislation, a hearing aid stands for any wearable instrument or device designed for, offered for, or represented as aiding persons with compensating for, impaired hearing. The FDA further explains that the scope of the definition provided hereinabove covers both air-conduction and bone-conduction devices. These products are falling within the scope of the definition of a medical device as prescribed by the FD&C, hence, should be subject to respective regulatory requirements. The Agency also mentions that implantable middle ear hearing devices and cochlear implants are not hearing aids, but Class III medical devices. Consequently, such products should be placed in the market under the premarket approval (PMA) pathway. At the same time, certain products intended to amplify sounds are not hearing aids, providing they are intended to be used by persons without hearing impairments. As described in the present guidance, such products should be considered PSAPs, which are explicitly excluded from medical device regulations. 

Under the current regulatory framework, hearing aid devices could be classified as follows:

  • Class I devices, exempt from premarket notification;
  • Class II devices, which require premarket notification and compliance with special controls before marketing;
  • Class II devices that are exempt from premarket notification, subject to required special controls. 

The document also provides a list of applicable product codes for various types of hearing aids. The authority also mentions that new codes could be added from time to time, should it be reasonably necessary to cover new medical devices based on novel technologies. 

The FDA also states that the scope of this guidance does not cover such products as the group hearing aid or group auditory trainer, master hearing aid, and tinnitus masker. 


Regulatory Requirements 

The guidance further describes in detail the particular regulatory requirements hearing aids are subject to by the existing regulatory framework. As it was mentioned before, hearing aids should be regulated as medical devices, while PSAPs shouldn’t. To assist medical device manufacturers and other parties involved in interpreting and applying respective legislation, the guidance provides additional clarifications regarding the intended uses of the above mentioned products and regulatory requirements these products are subject to. 

  1. Hearing Aids. Since hearing aids are considered medical devices, they should be subject to any regulatory requirements applicable for medical devices, including adverse event reporting. Moreover, there are certain device-specific requirements to be applied in the case of hearing aids. The FDA also mentions that since hearing aids are electronic products, they should also comply with the respective regulatory requirements. As explained in the present guidance, the regulatory requirements are intended to ensure medical devices allowed for marketing and use in the US are safe and effective, and all important information regarding the devices and the way they should be used is duly communicated to users. In particular, it should be understandable when a user being a layperson should contact a healthcare professional for advice and assistance. As further described by the Agency, the information provided in the documentation accompanying hearing aids should identify the situations when these devices should be used, as well as specific conditions that require additional attention and treatment. The information provided by the manufacturer should be sufficient for choosing the appropriate hearing aids that will meet the actual needs of a user. According to the guidance, hearing aids should also comply with the requirements outlined in 21 CFR 801.420, which outlines requirements in terms of labeling, including the scope of information to be provided in the label of the device and the instructions for use to be supplied with the device. Apart from this, the FDA refers to the respective guidance dedicated to the conditions for sale, issued previously by the FDA. 
  2. Personal Sound Amplification Products (PSAPs). As it was mentioned before, PSAPs are products that are not intended to compensate for hearing impairment. These products should be used by users without hearing issues. Hence, these products are not subject to regulation under the framework of the medical device. Consequently, there are no product codes or classification rules to be applied for these products. At the same time, PSAPs should comply with the respective requirements for electronic products, and all the incidents associated with these products should be duly reported as prescribed by the applicable rules. 
  3. The distinction between PSAPs and Hearing Aids. As it was mentioned before, the approach to be applied to distinguish hearing aids and PSAPs should be based on the intended use of a product in question. According to the guidance, a product’s intended use refers to the “objective intent” of those legally responsible for the labeling of the product, which may be shown by their oral or written expressions, the design or composition of the product, or by the circumstances surrounding the distribution of the product. Thus, if the purposes the product is intended for are not the purposes covered by the scope of the definition of a medical device as prescribed by the FD&C Act, this product should not be considered a medical device. 

In summary, the present FDA guidance describes hearing aids and PSAPs from the regulatory perspective, clarifies the way these products should be distinguished, and also provides an overview of the applicable regulatory requirements. The guidance highlights the main points to be considered by manufacturers when determining the regulatory status of products they are responsible for, and the particular framework to be applied. 



How Can RegDesk Help?

RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.