Full List of OTC Hearing Aids

by Abram Bailey, AuD

Navigating the World of OTC Hearing Aids

Intro by Bridget Dobyan, HIA Director of Public Policy & Advocacy

If you’re a regular reader of our blogs or turn on the news from time to time, you know that there is now another pathway available to addressing your hearing loss. In October 2022, a rule creating a new category of hearing aids known as “over-the-counter hearing aids” or “OTC hearing aids” became effective. OTC hearing aids are intended for use by adults (age 18 or over) with perceived mild to moderate hearing loss. All other hearing aids, now called “prescription hearing aids,” are available through a licensed hearing professional and are appropriate for all levels of hearing loss.

 

With the new OTC hearing aid category offering additional avenues to select and purchase hearing aids, navigating your hearing health can become overwhelming. If you think you may have hearing loss, it is still best to first see a licensed hearing professional, such as an audiologist or hearing aid specialist. Hearing professionals can test your hearing, help you understand the impact of treating your hearing loss, provide advice, answer questions, and review the options that are available to you.

 

If you’re like me, you also like to do your own research before making a purchase. There is a lot of information out there about OTC hearing aids, prescription hearing aids, and the new landscape for treating hearing loss. FDA provides a device classification database that includes medical device manufacturers registered with FDA and devices listed with FDA, including OTC hearing aids. To search for establishment registrations and device listings, visit the FDA’s Establishment Registration & Device Listing database. You can search using the name of the establishment, owner, name, product code, and more. Searchable hearing aid product codes include:

To help keep it all straight, our friends over at Hearing Tracker have put together a list of OTC hearing aids, distinctions within the new OTC category, and FDA product codes. Read on to learn about the options currently listed with the FDA, features that devices may offer based on product codes, new partnerships in the hearing health space, and more.

The old world of hearing aids

In the old world, there were two main categories of prescription air-conduction hearing aids:

• 874.3300 - Air-conduction hearing aid
• 874.3305 - Wireless air-conduction hearing aid

Note: Air conduction simply means that sound is transmitted through the air via sound waves. Other types of hearing aids transmit sound via bone vibration, electrical stimulation, etc.

Hearing aids falling within these two categories are intended for sale by state-licensed audiologists and hearing instrument dispensers. While the FDA does not require registrants to prove the effectiveness of their hearing aids, manufacturers do have to comply with standards for electrical safety, electroacoustic performance, biocompatibility, and bench verification testing. The primary difference between the two categories is that the latter, with its wireless transmissions and functionality, have additional requirements for electromagnetic and immunity testing.

Moving to the new world

In the new world of hearing aids, we still have the above existing categories, but also get a third group of self-fitting air conduction hearing aids:

• 874.3325 - Self-fitting air-conduction hearing aid

“Self-fitting” in this context simply means a wearable amplification device containing technology (e.g., software) that allows users with mild-to-moderate hearing loss to program their own devices. The technology takes the user's input and enables them to customize or select settings independently, rather than relying on a professional to be fitted.

This means the manufacturer must make the "tools, test, or software" easy to set up for the end user. The FDA has, thankfully, set a higher bar for manufacturers that wish to register their hearing aids as programmable. A user study must be performed to prove that the device can be used by consumers as intended and that the device is safe and effective.

Products that fall under the FDA's Section 874.3325 can all be sold directly to consumers, but there are two subclasses that dictate where the products can be sold, exactly:

• QDD - DTC hearing aid that may be sold online
• QUH - OTC hearing aid that may be sold online AND in stores, pharmacies, etc.

QDD was created in 2018 when the FDA granted de novo (new product category) status to the first Bose self-fitting hearing aid—a device that would never actually be sold commercially but was still subject to labeling and performance requirements. In effect, that product was the only air-conduction non-wireless hearing aid from that point forward to require 510(k) approval.

With the FDA's issuance of its Final Rules for OTC hearing aids in August 2022, the Agency essentially reorganized air-conduction hearing aids, keeping all of the original categories (including 874.3300 [ESD], 874.3305 [OSM] and 874.3325 [QDD]) and their existing product codes. For those that met the Final Rule requirements for OTC, a “new” product code was issued under each of the regulations for OTC intended use.  The previous product codes were maintained but (effective October 2022) were designated as prescription devices while the “new” product codes (QUF, QUG, and QUH) became the OTC versions of the same three listed above (874.3300 , -.3305, and -.3325).

For simplicity's sake, you can think of the big difference between QDD and QUH as being the labeling requirements. In the case of QUH (the OTC variety), product boxes will need to have very specific information about the intended use, risks, and contraindications of OTC hearing aids.

Example of new OTC label format (Credit: HP, Nuheara)

Preset-based hearing aids

We will also see a new product classifications for the old wireless (874.3305) and non-wireless (874.3300) air-conduction hearing aids:

• QUG - Preset-based OTC hearing aid, air-conduction with wireless technology
• QUF - Preset-based OTC hearing aid, air-conduction without wireless technology

In defining "self-fitting" vs "preset-based", the FDA states that "a hearing aid outputting a preset likely would not be self-fitting, but a hearing aid that allowed the user to make frequency dependent modifications to a preset to suit the user’s preferences likely would be self-fitting."

Generally speaking, an OTC hearing aid that uses testing and fitting software to measure your hearing ability at several frequencies (pitches) and then program the aid accordingly will be more precise than an OTC hearing aid that simply uses a series of presets designed to correct for an “average hearing loss” type. For some people with milder forms of hearing loss, this distinction may not be as critical. However, if you have moderate hearing loss and/or more complex hearing needs, then you'll likely get better performance from a self-fitting hearing aid that can be programmed for your own unique hearing profile (i.e., having the volume adjusted in each available frequency).

Another major difference between OTC self-fitting and preset-based hearing aids is that the FDA does not require the same rigorous testing of preset-based hearing aids. And from a manufacturer's standpoint, it's much easier and less expensive to build a simple hearing aid with presets than a more sophisticated software-based device—meaning this product class is more likely to attract companies looking to make a quick buck. Having said this, there are sure to be some good pre-set products. Just proceed more cautiously if you purchase a QUG- or QUF-classified hearing aid.

Summary of discussed product codes

That's a lot to take in. Here's a helpful cheat sheet of all the product codes discussed (OSM discussed in the section about Eargo, below):

FDA-registered self-fitting and preset-based hearing aids

Without further ado, here's the comprehensive list of hearing aids that are registered with the FDA as self-fitting or preset-based, based on the three product codes discussed above:

List of OTC and self-fitting hearing aids *additional number product variants not shown **Search the FDA's Establishment Registration & Device Listing for a full list of products using the product code QUF.

What about Lexie, Sony, Jabra and HP?

If you're following the OTC hearing aid space, you've probably come across ads for Lexie, Sony, and HP branded OTC hearing aids. This is where things get a little more complicated. We've seen a lot of branding partnerships in the hearing aid industry, where OTC hearing aid manufacturers partner up with well known consumer electronic brands to gain market traction.

As an addendum to the table above, here are some of the notable branding partnerships to be aware of:

Branding partnerships in OTC hearing aids. These products are all FDA 510k cleared self-fitting DTC and OTC products.

There is still time for OTC manufacturers to comply with FDA regulations

There still may be a number of companies selling hearing aids online that are not actually registered under any of the direct-to-consumer FDA classes. Some may be registered under the product code OSM. OSM is reserved for prescription-based wireless air-conduction hearing aids falling under the old 874.3305 regulation number. Consumers should be aware that, like QUG and QUF products, the FDA does not require OSM products to undergo the type of safety and efficacy testing required of self-fitting OTC hearing aids.

If these companies want to sell their products as OTCs after April 18, 2023—the end of the 6-month grace period after the rules were published in the Federal Register—they will need to comply with the FDA's labeling requirements for OTCs, and if categorized as self-fitting (rather than preset-based), they will also need to cleared by the FDA for safety and efficacy.

A good example of this is Eargo, a company that had products listed under the OSM code. Because their products were Class I or Class II exempt air conduction hearing aids, they had 240 days after the FDA's OTC rules were published in the Federal Register to achieve compliance with the new requirements, including labeling. The company received FDA 510(k) clearance for Eargo 5 and 6 as self-fitting hearing aids on December 22, and Eargo says it is launching Eargo 7 as its third over-the-counter self-fitting device.

In a news release prior to receiving FDA clearance, Eargo's CEO Christian Gormsen stated: "Based on our initial review of the final rule, we believe Eargos can continue to be sold under existing regulations as well as classified as OTC hearing aids, subject to compliance with labeling and other requirements of the final rule. For example, we believe Eargo hearing aids currently on the market are within the FDA’s output and insertion depth limit requirements."

So the bottom line is that some products are permitted to be sold as OTC hearing aids so long as they comply with the current regulatory requirements and gain clearance by April 18.

See a product missing from the list?

If you're curious about a product and don't see it on the list, please let us know in the comments. We'll double check the FDA databases to ensure we're up to date, and do some snooping to see if there's a new secretive brand partnership we need to document.

Notes

†We rely on the FDA's web-based databases for updating this list. Some products may be registered with or approved by the FDA before showing up on the FDA's publicly-available databases. These products will be missing from our list until they are listed by the FDA.

Not all OTC hearing aids, regardless of regulation number or product code, will appear in the FDA's list of approved hearing aids (see the above discussion that cites Eargo as an example).