FDA-approved OTC hearing aids – what buyers and distributors need to know

With the US FDA allowing the sale of OTC hearing aids, the global market has changed – hearing aid distributors must understand the impact. The most important topic for hearing-impaired users: Are OTC hearing aids effective and worth buying?

For hearing aid users

Overall, OTC hearing aids provide a cost-effective hearing solution for users with limited budgets and minimal hearing loss. OTC hearing aids are suitable for people with mild to moderate to severe hearing loss, do not require a prescription, are inexpensive, usually between $100-$600, are easy to operate, suitable for daily use, and are convenient to purchase online and offline. However, OTC hearing aids cannot be customized to meet the needs of patients with severe hearing needs. It is advisable to consult with an audiologist before purchasing to ensure that you choose the most suitable hearing aid.

For Hearing Aid Distributors

AUSTAR Hearing is one of the most trusted hearing aid manufacturers in China, our advantages:

• Over 20 years of experience
• CE 1639, ISO13485 and FDA certifications
• Advanced manufacturing processes and strict quality control systems

For distributors selling hearing aids in the US and European markets, safety and compliance are top priorities. Choosing AUSTAR Hearing means that you choose a hearing aid brand that ensures:

• Hearing aids comply with FDA OTC regulations
• CE certification for EU distribution
• Professional packaging and customs clearance documents

What does this mean for your hearing aid business?

• You can avoid legal and regulatory risks
• Compliant labels increase consumer trust
• Get certified, ready-to-sell products to increase your competitive advantage

Hearing aid OEM

As more and more customers seek safe, effective and affordable hearing solutions, working with a proven OEM like AUSTAR Hearing ensures you stay ahead of hearing aid market trends and competitors.