Full List of OTC Hearing Aids

There is a ton of confusion when it comes to over-the-counter (OTC) hearing aids. While numerous hearing aids are sold directly to consumers online, many of these products are not technically OTCs. The FDA has established clear regulatory distinctions between prescription hearing aids, self-fitting OTC hearing aids, and preset-based OTC hearing aids.

The Old World of Hearing Aids

Traditionally, there were two main categories of prescription air-conduction hearing aids, which still exist today:

• 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.

The New World of Hearing Aids

In the new world of hearing aids, we get three new classes of OTC hearing aids:

1. Self-fitting OTC hearing aids - Amplification adapts to your unique hearing pattern
2. Preset-based OTC hearing aids - You select from existing generic amplification profiles
3. Hearing aid software - Converts your existing hardware into a pair of OTC hearing aids.

These new classifications expand consumer access to hearing technology, allowing individuals with mild-to-moderate hearing loss to purchase, set up, and customize their own hearing aids without visiting a licensed professional. Unlike traditional prescription hearing aids, which require professional fitting, these new categories are designed for direct-to-consumer sales and prioritize ease of use.

If you're curious about how both worlds compare, read our OTC vs. prescription hearing aids analysis.

"Self-Fitting" Hearing Aids

“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.

Preset-Based Hearing Aids

In addition to self-fitting OTC hearing aids, the FDA has also introduced preset-based 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 programs 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.

The Latest Addition: Hearing Aid Software as a Medical Device

With Apple’s De Novo classification request, the FDA has now introduced a new regulatory category for software-based hearing aids:

• 874.3335 (Product code: SCR) – Air-conduction hearing aid software

This new category represents a fundamental shift in hearing aid technology. Unlike traditional self-fitting hearing aids that include both hardware and software, hearing aid software can now be regulated as a standalone medical device, provided it runs on approved hardware. Apple’s Hearing Aid Feature is the first software-only hearing aid to receive FDA clearance and is intended for use with AirPods Pro (2nd generation).

How Does Apple's Hearing Aid Feature Work?

Apple's software meets the FDA’s self-fitting requirements, allowing users to program amplification settings via their iPhone. The Hearing Aid Feature (HAF) consists of two parts:

1. HAF iOS Application – Runs on a compatible iOS device, guiding users through a self-fitting process using an audiogram.
2. HAF Firmware – Runs on Apple AirPods Pro 2, storing and applying the user’s hearing settings.

Users must import an audiogram from Apple’s Hearing Test Feature or a licensed professional into the Health App. The software then adjusts amplification levels based on Apple's proprietary fitting formula.

Importantly, Apple’s software is classified as Over-the-Counter (OTC), meaning it is intended for users 18 and older with mild-to-moderate hearing loss and does not require professional fitting.

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):

For consumers, the biggest takeaway is that self-fitting hearing aids and hearing aid software offer the most personalization, while preset-based hearing aids may be a lower-cost but less flexible alternative.

Self-Fitting Hearing Aids

Without further ado, here's the comprehensive list of hearing aids that are registered with the FDA as self-fitting hearing aids. We'll break the list down by country and summarize the products offered by each company.

Preset-Based OTC Hearing Aids

Here's a comprehensive list of all preset-based OTC hearing aids listed by the FDA:

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:

Final Thoughts

The hearing aid market is changing fast, and new options like Apple's Hearing Aid Feature signal a shift toward software-driven solutions. While the best hearing aid for you depends on your specific hearing needs, it's crucial to understand the differences between prescription, self-fitting, preset-based, and software-only hearing aids before making a purchase.

If you're considering an OTC hearing aid, keep in mind:

• Self-fitting OTC hearing aids (QUH/QDD) offer the most customization.
• Preset-based OTC hearing aids (QUG/QUF) are more affordable but less adjustable.
• Hearing aid software (SCR) can turn compatible devices into hearing aids.

As new products emerge, always check FDA classifications to ensure you're purchasing a legitimate, regulated device.

Further Reading: Background on OTC Product Codes

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.