The FDA OTC rule: what changed in 2022

The FDA's Over-the-Counter Hearing Aid Rule, finalized in August 2022 and effective October 2022, created a new regulatory category for hearing aids that can be sold directly to consumers without a prescription, audiogram, or professional fitting. The rule implemented a provision of the Over-the-Counter Hearing Aid Act of 2017, which was included in the FDA Reauthorization Act signed by President Trump.

Key provisions of the OTC rule:

• OTC hearing aids are for adults 18 and older with perceived mild to moderate hearing loss
• No audiogram, prescription, or professional involvement is required for purchase
• Devices must meet FDA output limits (maximum OSPL90 of 117 dB SPL, maximum gain of 25 dB for self-fitting devices)
• Devices must include labeling with conditions for which professional consultation is recommended
• State laws requiring audiologist or dispenser involvement in hearing aid sales were preempted for OTC devices
• Prescription hearing aids remain unchanged — the OTC category is additive, not replacing prescription care

The rule explicitly does not apply to children under 18, patients with severe or profound hearing loss, or patients with medical contraindications (asymmetric loss, sudden loss, tinnitus, drainage, pain, or visible deformity) — all of whom should be referred for professional evaluation.

Clinical implications for audiologists

The OTC rule has several significant clinical implications:

• New patient pathways: Many patients will try OTC aids before seeking professional care. Audiologists will increasingly see patients who have OTC experience — some satisfied, some not. Understanding OTC technology and its limitations is essential for counseling these patients.
• Scope of practice clarification: The OTC rule does not change the scope of practice for audiologists. Audiologists can still evaluate, fit, and dispense hearing aids to all patients, including those who could theoretically self-fit with OTC devices. The professional value proposition is verification, validation, and comprehensive care — not gatekeeping access.
• Fitting accuracy: OTC self-fitting algorithms cannot match the precision of REM-verified prescriptive fitting. Studies comparing OTC self-fitting to audiologist-fitted devices consistently show that professional fitting produces better audiometric outcomes, particularly for patients with more complex audiograms.
• Patient selection: The OTC rule's output limits mean that OTC devices are genuinely inappropriate for patients with more than mild to moderate loss. Audiologists play a critical role in identifying patients who need prescription care and counseling OTC users who are not getting adequate benefit.

Counseling patients who have tried OTC aids

Patients who present after trying OTC aids require specific counseling approaches:

• Acknowledge their experience: Validate that OTC aids represent a legitimate first step. Avoid dismissing or criticizing their OTC experience — this damages trust and may make patients defensive.
• Identify what worked and what didn't: Ask specifically about situations where the OTC aids helped and situations where they didn't. This information guides the fitting and helps set realistic expectations for prescription aids.
• Explain the difference: Help patients understand how professional fitting differs — audiogram-based prescriptive targets, real-ear verification, and ongoing follow-up. Emphasize that the goal is to optimize the hearing aid for their specific hearing loss, not just to amplify sound.
• Address the cost difference: Patients who have paid $500–$1,500 for OTC aids may be reluctant to spend $3,000–$7,000 for prescription aids. Be prepared to discuss the value of professional fitting and the evidence for better outcomes.
• Consider OTC as a stepping stone: For some patients, OTC experience increases motivation for professional care. They have experienced some benefit and want more — this is a strong motivational foundation for the fitting process.

Integrating OTC into practice

Some audiologists are exploring ways to integrate OTC hearing aids into their practice model:

• OTC fitting services: Offering professional fitting and verification services for patients who have purchased OTC aids. This provides value to OTC users while generating revenue for the practice.
• Tiered care models: Offering a range of service levels — from basic OTC fitting assistance to comprehensive prescription fitting — to serve patients across the cost spectrum.
• OTC counseling appointments: Brief appointments to assess OTC aid performance, verify fit, and counsel patients on appropriate use and limitations. These can be positioned as a low-cost entry point that may lead to prescription care.
• Telehealth OTC support: Remote support for OTC users who need guidance but cannot or will not come to a clinic.

The evidence on OTC outcomes

Early research on OTC hearing aid outcomes is emerging. Key findings:

• Self-fitting OTC aids can provide meaningful benefit for patients with mild to moderate hearing loss — several studies show significant improvement in speech understanding and quality of life measures.
• Professional fitting consistently produces better audiometric outcomes than self-fitting, particularly for patients with more complex audiograms or greater degrees of loss.
• Patient satisfaction with OTC aids is variable — some patients are highly satisfied, others are not. Satisfaction correlates with degree of loss (milder loss = better OTC outcomes) and technology quality.
• The Lancet Commission on Hearing Loss (2023) estimated that OTC hearing aids could significantly increase hearing aid adoption rates, particularly in underserved populations — a public health benefit that audiologists should acknowledge even while advocating for professional care.