US medical device regulators have released a new draft guidance regarding requirements for manufacturers and marketers of hearing aids and personal sound amplification products (PSAPs), saying that important distinctions exist between the two types of devices despite their similar use.
Both hearing aids and PSAPs share, in theory, a similar purpose: making it easier for the end user to hear. Though the former are prescription devices, the latter are not, and are commonly marketed for people who may not have hearing loss, but may wish to amplify their hearing in certain situations (say, being able to hear a quiet TV in a room where someone else is sleeping). Though their intended uses are different, the technology behind them can be extremely similar, leading to the potential for overlap and confusion among consumers.
Despite those similarities, the different intended uses subject the devices to different legal and regulatory controls, the US Food and Drug Administration (FDA) explains in its new draft guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products.
"The intended use may be established by labeling or promotional materials," FDA explained. "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, as described in this guidance."
For example, if a company made a claim that its device is to be used by a person with a type of hearing loss, in situations indicative of hearing loss, or makes a claim that a device is an alternative to a hearing aid, it would be considered a medical device and regulated as such.
A Guidance on Definitions
FDA's guidance serves two functions: to explain what a hearing aid and PSAP are, and what they are not.
For example, hearing aids are defined under 21 CFR 874.3300 as a "wearable sound-amplifying device that is intended to compensate for impaired hearing." The word "wearable" also means that the devices are not implantable, such as cochlear implants or implantable middle ear hearing devices, which are regulated differently (and often more stringently). By contrast, hearing aids are generally regulated under Class I general controls.
Crucially, hearing aids are also available only by prescription.
PSAPs, by contrast, are available without a prescription but are intended for non-hearing-impaired consumers. Intended uses include things like bird watching, hunting or listening to a specific person or object in an otherwise difficult situation (e.g. because of distance between the user and the speaker). As FDA notes, "They are intended to accentuate sounds in specific listening environments, rather than for everyday use in multiple listening situations."
As FDA's guidance makes clear, marketers of PSAPs will have a fine line to tread if they wish to remain compliant under the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR 874. FDA said many situations can be indicative of hearing loss, including:
- 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
- difficulty listening in situations in which environmental noise might interfere with speech intelligibility
"Products making these or similar claims should not be considered PSAPs," said FDA. In addition, if a company markets a PSAP as being an "alternative" to a hearing aid without first having obtained approval from FDA, it would automatically not be considered a PSAP.
Comments on the guidance will be accepted by FDA through 5 February 2013.
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
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