What Are OTC Hearing Aids and Are They Effective?

Over-the-counter (OTC) hearing aids are changing the way people access hearing help. With FDA approval since 2022, these devices offer an affordable, accessible solution for millions with mild to moderate hearing loss. For distributors and retailers, OTC hearing aids represent a fast-growing market opportunity. Brands like Cadenza now offer FDA-registered OTC hearing devices tailored for global distribution, making it easier than ever to enter the hearing aid business.

What Are OTC Hearing Aids?

OTC hearing aids are devices sold without a prescription, designed for people over 18 with mild to moderate hearing loss. They can be bought online, in stores, or at pharmacies, and often include self-fitting features and volume controls.

Are OTC Hearing Aids Effective?

Yes—modern OTC hearing aids are effective when used appropriately. They:

• Help users hear better in quiet or noisy environments
• Include features like Bluetooth streaming, noise reduction, and rechargeable batteries
• Are easy to use and adjust without a hearing professional

However, they’re not meant for severe hearing loss or medical conditions that require audiological evaluation.

For Hearing Aid Distributors: Why This Matters

The OTC category is a fast-growing opportunity for hearing aid distributors. Cadenza offers:

• FDA-registered OTC models
• CIC, RIC and BTE styles with instant-fit design, No need for professional fitting.
• Bluetooth and rechargeable options
• Full OEM/ODM support
  

OTC hearing aids are not just effective—they're also transforming the global hearing care market. For distributors, this is a chance to offer an affordable, high-demand medical device with regulatory backing. If you’re a hearing aid distributor or brand looking to expand into hearing solutions, now is the time to explore OTC hearing aids from a trusted OEM supplier like Cadenza.