Can you wear hearing aids (hearing devices) without a prescription from a healthcare professional, such as an audiologist or an Ear, Nose, and Throat (ENT) specialist?

Can You Wear Hearing Aids Without a Prescription?

Yes, you can now wear certain hearing aids without a prescription—specifically over-the-counter (OTC) hearing aids, which became available in the United States following FDA regulations that do not require a medical evaluation or audiologist appointment prior to purchase. 1

Regulatory Framework

• As of 2017, the FDA Reauthorization Act created a new category of OTC hearing aids that can be purchased without prescription, medical evaluation, or audiologist consultation 1
• In 2004, the FDA cleared labeling for at least one commercially available hearing aid without prescription requirement, with expectations that more would follow 2
• Historically, most hearing aids were classified as Class 3 medical devices requiring prescriptions, with the goal of ensuring organized programs with appropriate training and oversight 2

Types of Amplification Devices Available Without Prescription

OTC hearing aids and personal sound amplification products (PSAPs) are available without prescription and can be appropriate for mild to moderate hearing loss. 2

• OTC hearing aids: Designed for adults with perceived mild to moderate hearing loss and available directly to consumers 1
• Personal sound amplification products (PSAPs): Less expensive than conventional hearing aids but lack sophisticated components for addressing narrow dynamic range and distortion 2
• Assistive listening devices (ALDs): Can be purchased without prescription for specific listening situations 2

When Professional Evaluation Is Still Necessary

Despite OTC availability, professional evaluation remains critical for identifying underlying ear disease, optimizing outcomes, and ensuring appropriate device selection. 3, 4

• In one study, only 50% of patients referred for hearing aids would have been appropriately fitted without specialist opinion; the remainder either didn't need hearing aids or required further investigation and treatment 3
• Among patients with hearing loss, 31 had chronic otitis media on examination, but only 45% were identifiable from referral information alone 4
• Active inflammatory ear disease was missed in referral letters in 3 of 8 cases 4

Clinical Considerations for OTC Hearing Aids

Modern digital hearing aids often require programming or manual adjustment by professionals as hearing loss fluctuates or progresses, which may limit the effectiveness of self-fitted OTC devices. 2

• Appropriately fitted amplification should be offered to all patients with age-related hearing loss, as it can improve quality of life, communication, mental health, social functioning, and potentially delay cognitive decline 2
• Amplification benefits are maximized when devices are properly fitted to individual hearing loss patterns 5
• Newer technology may allow patients to self-test hearing and adjust output, though professional fitting typically yields better outcomes 2

Important Caveats

• Cost barriers: Hearing aids are expensive and typically not covered by Medicare or many private insurance companies, making OTC options attractive but potentially less effective 2
• Risk of inappropriate use: Without professional evaluation, underlying treatable conditions (middle ear disease, cholesteatoma, acoustic neuroma) may be missed 6, 3, 4
• Limited benefit scenarios: When hearing loss progresses to severely compromised word recognition scores or narrow dynamic range, conventional amplification may worsen hearing, requiring specialized devices like CROS hearing aids or cochlear implants 2
• Pharmacist consultation: Patients purchasing OTC hearing aids at pharmacies may benefit from collaborative relationships between pharmacists and audiologists for guidance 1

Recommendation Algorithm

1. For mild to moderate self-perceived hearing loss: OTC hearing aids or PSAPs can be tried without prescription 2, 1
2. If no improvement or worsening symptoms: Seek professional evaluation to rule out treatable ear disease 3, 4
3. For moderate to severe hearing loss: Professional fitting with prescription hearing aids is strongly recommended for optimal outcomes 2
4. For severe to profound hearing loss: Specialized devices (CROS, bone-anchored devices, cochlear implants) require professional evaluation and fitting 2