FDA OTC Hearing Aid Regulation: Product Codes & MAUDE Adverse Events

The FDA's establishment of the Over-the-Counter (OTC) hearing aid category represents one of the most significant structural shifts in consumer medical device regulation in recent decades. By removing the requirement for a medical examination, prescription, or audiologist fitting, the FDA sought to lower costs and increase access for adults with perceived mild-to-moderate hearing impairment. However, this deregulation did not strip OTC hearing aids of their medical device status; instead, it created a dual-regulatory pathway that splits the air-conduction hearing aid market into distinct prescription and OTC product codes.

For medical device manufacturers, regulatory affairs professionals, and market-access strategists, navigating this landscape requires a precise understanding of product codes (QUF, QUG, and QUH), 510(k) clearance requirements, labeling conditions for sale, and post-market surveillance. This guide provides a detailed analysis of the FDA regulatory framework for OTC hearing aids, compares them to prescription systems and Personal Sound Amplification Products (PSAPs), and teardowns adverse event data from the Manufacturer and User Facility Device Experience (MAUDE) database.

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Executive Summary: OTC Hearing Aid Regulatory Landscape

• First-Screen Answer / Scenario Question Summary: To bring an OTC hearing aid to the US market, manufacturers must align their product with one of three primary product codes: QUF (Class I, 510(k)-exempt preset devices), QUG (Class II, non-exempt preset wireless devices), or QUH (Class II, non-exempt self-fitting wireless devices). These are distinct from prescription codes (ESD/OSM/QDD) and from Personal Sound Amplification Products (RHO), which are not medical devices. As of November 2023, approximately 54 companies had listed devices under QUF and 18 under QUH.
• 510(k) Clearance Volume: An analysis of historical openFDA 510(k) clearances reveals 1,503 hearing-related clearances. The dataset is heavily dominated by prescription air-conduction hearing aids under code ESD with 1,367 clearances (90.9%). In contrast, self-fitting OTC hearing aids under code QUH have only 10 clearances, while preset wireless OTC devices (QUG) have 1 clearance, reflecting the early stage of this commercial category.
• MAUDE Post-Market Surveillance Signal: In 2024, MAUDE logged 1,887 reports associated with hearing devices. However, this safety signal is almost entirely driven by bone-conduction and implantable devices (product codes PFO, MAH, LXB, and MPV), which represent the majority of reports. Prescription wireless air-conduction devices (OSM) generated 188 reports, while traditional prescription air-conduction devices (ESD) generated 16 reports. The newly established OTC product codes (QUF/QUG/QUH) contributed almost no reports to the 2024 database.
• Administrative Recoding: The FDA active-reclassification process is exemplified by products like the Jabra Enhance Plus (originally cleared under prescription codes), which was administratively recoded under QUH to align with the self-fitting OTC framework.
• Strategic Takeaway: While the OTC category reduces barriers to entry, manufacturers must maintain strict compliance with electroacoustic performance limits, labeling constraints, and post-market reporting. The emergence of software-only hearing features (such as Apple's Hearing Aid Feature under code SCR) further demonstrates the need for manufacturers to integrate software development lifecycle standards (like IEC 62304) into their regulatory planning.

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The History of the FDA OTC Hearing Aid Rule

The regulatory pathway for OTC hearing aids was established by Congress under Section 709 of the FDA Reauthorization Act of 2017 (FDARA). This statute mandated that the FDA establish a category for over-the-counter hearing aids, defining their safety, efficacy, and labeling requirements.

The subsequent regulatory timeline progressed through several key phases:

1. Executive Order (July 2021): President Biden issued an Executive Order on Promoting Competition in the American Economy, which specifically directed the Department of Health and Human Services (HHS) and the FDA to publish a proposed rule for OTC hearing aids within 120 days.
2. Proposed Rule (October 2021): The FDA published a proposed rule, receiving more than 1,000 public comments from manufacturers, audiologists, consumer advocacy groups, and the public. Key areas of debate centered on maximum output limits, insertion depth guidelines, and whether state-level preemption rules would apply.
3. Final Rule (August 17, 2022): The FDA published the final rule, titled "Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids" (87 FR 50698), which established the formal regulations under 21 CFR § 800.30.
4. Effective Date (October 17, 2022): The final rule took effect, allowing manufacturers to begin listing Class I 510(k)-exempt OTC hearing aids and submitting 510(k) notifications for Class II self-fitting systems.

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FDA Product Codes: OTC vs. Prescription vs. PSAP

A key challenge for regulatory teams is distinguishing between the different categories of hearing-support devices. The FDA maintains a clear distinction based on the device's technology, intended user population, and whether the device is sold directly to the consumer.

Below is the comparative matrix for the primary product codes under this framework:

Product Code	Regulation Number	Device Class	510(k) Status	Intended Use / Clinical Channel
QUF	21 CFR 874.3300	Class I	Exempt	OTC; adults (18+) with perceived mild-to-moderate loss; air-conduction with preset programs.
QUG	21 CFR 874.3305	Class II	Non-Exempt	OTC; adults (18+) with perceived mild-to-moderate loss; wireless preset controls.
QUH	21 CFR 874.3325	Class II	Non-Exempt	OTC; adults (18+) with perceived mild-to-moderate loss; self-fitting with software interface.
ESD	21 CFR 874.3300	Class I	Exempt	Prescription; all ages; air-conduction with clinician-fitting presets.
OSM	21 CFR 874.3305	Class II	Non-Exempt	Prescription; all ages; wireless preset controls.
QDD	21 CFR 874.3325	Class II	Non-Exempt	Prescription; all ages; self-fitting software controls.
RHO	Not a medical device	Class N (Non-Med)	N/A	Personal Sound Amplification Product (PSAP); non-hearing-impaired users (e.g., bird watching, hunting).
SCR	21 CFR 874.3335	Class II	Non-Exempt	Software-only OTC hearing aid (e.g., Apple's Hearing Aid Feature).

The Intended Use Boundary: Hearing Aids vs. PSAPs (RHO)

The boundary between a medical hearing aid (QUF/QUG/QUH) and a Personal Sound Amplification Product (RHO) is determined entirely by the device's intended use.

Under the FDA's guidance document, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, a device is classified as a hearing aid if its labeling, marketing, or design indicates it is intended to compensate for hearing impairment. In contrast, a PSAP is classified as an electronic product (not a medical device) if it is marketed solely for non-hearing-impaired users to amplify environmental sounds in specific settings (e.g., recreational hunting, bird watching, or listening to a distant speaker).

Manufacturers must exercise caution: if a PSAP's marketing implies it can help users with mild hearing loss, the FDA will reclassify the product as an un-cleared medical device, leading to enforcement action. This boundary is similar to other consumer-adjacent medical classifications, such as those analyzed in our borderline product classification teardown and the aesthetic medical device regulatory guide.

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510(k) Exemption Status and Conditions for Sale

A major benefit of the OTC final rule is that it established 510(k) exemption for Class I air-conduction hearing aids under 21 CFR § 874.3300. This means that a manufacturer bringing a basic preset OTC device (product code QUF) to market does not need to submit a pre-market notification or wait for FDA clearance. Instead, they can register their establishment, list their device, and begin commercial sales, provided they comply with the FDA's general controls and specific conditions for sale.

Conditions for Sale for 510(k)-Exempt OTC Hearing Aids (QUF)

To maintain 510(k)-exempt status, a QUF device must comply with strict electroacoustic and physical limits:

1. Output Limits: The maximum output of the device must not exceed 111 dB SPL under normal operating conditions. An exception applies to devices with input-controlled compression activated, which may have a maximum output of 117 dB SPL.
2. Electroacoustic Limits: The device must meet minimum performance standards for total harmonic distortion (not exceeding 5% at key test frequencies), latency (not exceeding 15 milliseconds), and self-generated noise (not exceeding 32 dBA).
3. Physical Design: The device must be designed for user insertion and removal, and the insertion depth must not extend beyond the bony portion of the ear canal. The device must also utilize materials that are biocompatible under ISO 10993 standards.
4. Labeling Requirements: The packaging must display a standardized "Quick Start Guide" with specific warning language (e.g., advising users to see a doctor if they experience ear pain, drainage, or sudden hearing loss). The labeling must also clearly state that the device is intended only for adults aged 18 and older.

When is a 510(k) Required? (QUG and QUH)

If an OTC hearing aid incorporates wireless technology (such as Bluetooth streaming or remote control apps) or utilizes self-fitting software (such as a smartphone-based hearing test that automatically programs the device's gain), it loses its 510(k)-exempt status:

• QUG (Wireless Preset): Requires a 510(k) submission under 21 CFR § 874.3305 because wireless transmission introduces potential electromagnetic interference (EMI) risks and software security concerns.
• QUH (Self-Fitting Wireless): Requires a 510(k) submission under 21 CFR § 874.3325. Self-fitting devices must demonstrate that the consumer can successfully perform the hearing assessment and program the device without clinician oversight. The 510(k) must include clinical usability data showing that the self-fitting algorithm performs comparably to a professional fitting.

Case Study: The Reclassification of Jabra Enhance Plus

The Jabra Enhance Plus (developed by GN Hearing) was originally cleared by the FDA under the prescription wireless product code (OSM) via the 510(k) process (K213424). Following the effective date of the OTC final rule in October 2022, the FDA initiated an administrative recoding process.

Because the Jabra Enhance Plus was designed for direct-to-consumer sales and incorporated a user-driven self-fitting app, the FDA reclassified the device under the newly established self-fitting OTC product code QUH. This transition demonstrated how existing pre-market clearances were mapped into the new regulatory categories, allowing manufacturers to market cleared devices as official OTC products without submitting new 510(k) files.

The Rise of Software-Only Hearing Aids (SCR)

In September 2024, the FDA authorized the first software-only OTC hearing aid: Apple's Hearing Aid Feature (HAF). Regulated under product code SCR, HAF is a software clinical function that runs on compatible models of the Apple AirPods Pro.

Using the smartphone's microphone and a self-administered audiometry app, the software measures the user's hearing thresholds and automatically configures the AirPods to act as an OTC hearing aid. This software-as-a-medical-device (SaMD) authorization highlights how the OTC framework is shifting from physical hardware toward software-driven platforms, forcing manufacturers to implement robust software lifecycle controls.

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510(k) Clearance Volume Analysis

To evaluate the commercial development of the hearing aid market, we analyzed the openFDA 510(k) database. Filtering for ear, nose, and throat (ENT) devices matching the hearing aid code set yielded 1,503 clearances historically.

The table below outlines the distribution of clearances across product codes:

Product Code	Description	510(k) Clearances	Percentage	Commercial Status
ESD	Prescription Preset Air-Conduction	1,367	90.9%	Dominates historical volume; many listings are legacy Class I clearances.
LXB	Bone-Conduction Hearing Aid	51	3.4%	Niche clinical category for conductive hearing loss.
EPF	Hearing Aid, Console (Clinician Fitting)	32	2.1%	Specialized audiologist programming consoles.
MAH / PFO	Implantable/Surgical Bone-Conduction	22	1.5%	Surgical implants (e.g., Cochlear Baha, Med-El).
QUH	OTC Self-Fitting Wireless	10	0.7%	Emerging B2B category (e.g., Sony, Jabra, Lexie).
QDD	Prescription Self-Fitting Wireless	7	0.5%	Prescription-based self-fitting systems.
QUG	OTC Preset Wireless	1	0.1%	Rarely used; manufacturers prefer QUF or QUH.
Others	Specialized Codes	13	0.8%	Custom earmolds and diagnostic interfaces.

This analysis reveals that prescription air-conduction devices (ESD) represent 90.9% of all clearances. The OTC self-fitting code QUH has only 10 clearances, indicating that while the OTC market has generated significant consumer interest, the number of cleared self-fitting systems remains small.

This presents a major opportunity for new market entrants: a cleared QUH device represents a highly competitive, clinically validated product in a market still dominated by basic, 510(k)-exempt preset devices (QUF).

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Post-Market Surveillance and MAUDE Database Insights

To evaluate the post-market safety profile of hearing devices, we analyzed the FDA's MAUDE database.

2024 MAUDE Volume and Event Distribution

In 2024, MAUDE logged 1,887 reports associated with hearing devices and implants. The event type distribution highlights the unique safety profile of these products:

• Patient Injuries: 1,588 reports (84.2% of total)
• Device Malfunctions: 298 reports (15.8% of total)
• Patient Deaths: 1 report (0.05% of total)

At first glance, the high percentage of patient injuries (84.2%) suggests a high-acuity safety profile. However, a deep dive into the product codes reveals that this signal is driven almost entirely by implantable and surgical bone-conduction devices, not standard air-conduction hearing aids.

2024 MAUDE Volume by Product Code

Breaking down the 1,887 reports by product code reveals the source of the safety signal:

Product Code	Device Type / Clinical Family	2024 MAUDE Reports	Percentage	Key Drivers
PFO	Surgical Implantable Bone-Conduction	724	38.4%	Cochlear Baha, Med-El Osia
MAH	Transcutaneous Bone-Conduction Implant	625	33.1%	Cochlear Osia, Oticon Medical
LXB	Non-Implanted Bone-Conduction Aid	233	12.3%	Headband-mounted bone conduction processors
OSM	Prescription Wireless Hearing Aid	188	10.0%	Major Rx brands (Phonak, Oticon, Resound)
MPV	Active Middle-Ear Implant	80	4.2%	Surgical middle-ear implants
ESD	Prescription Air-Conduction Hearing Aid	16	0.8%	Traditional prescription aids
QUF/QUG/QUH	OTC Hearing Aid Codes (All Families)	0	0.0%	Negligible post-market reporting
Others	Unclassified / Custom Codes	21	1.1%	Custom ear molds

The Surgical Dominance of Hearing MAUDE Reports

The MAUDE data demonstrates that surgical implantable bone-conduction devices (PFO and MAH) account for 71.5% of all reports. The patient injuries reported for these codes are primarily surgical site complications, such as skin flap infections, implant extrusion, local tissue inflammation, or osseointegration failures.

In contrast, standard air-conduction hearing aids (ESD and OSM) generate very few reports (10.8% combined). The new OTC categories (QUF, QUG, and QUH) contributed almost no reports to the 2024 database.

This low reporting rate is due to three factors:

1. Low Acuity: Air-conduction hearing aids are non-invasive, low-risk devices. A device failure typically results in a simple loss of amplification, which is handled as a commercial return or repair rather than a formal medical device report (MDR).
2. Under-Reporting: Direct-to-consumer buyers are less likely to report malfunctions to the manufacturer or the FDA compared to clinical audiologists or ENT surgeons.
3. Recent Implementation: The OTC category is still relatively new, and the post-market reporting infrastructure for consumer buyers is less developed.

FDARA § 709(d) Congress Reporting Mandate

Recognizing the potential for under-reporting in the consumer channel, Congress included Section 709(d) in FDARA. This statute requires the FDA to submit a report to Congress analyzing adverse events associated with OTC hearing aids, with a focus on identifying unique safety trends, user errors, or instances of delayed medical treatment for underlying ear conditions. This ongoing oversight pressure means that manufacturers must maintain robust post-market surveillance systems to capture consumer feedback, even if traditional MAUDE volume remains low.

Academic Context: Cureus 2025 Hearing Aid MAUDE Review

The low adverse-event rate for air-conduction hearing aids is supported by peer-reviewed literature. A 2025 study published in Cureus (Lu Q et al., Review of Reported Adverse Events Associated With Prescription Hearing Aids in MAUDE) analyzed historical MAUDE data for prescription devices.

The study concluded that the incidence of serious adverse events associated with air-conduction hearing aids is extremely low, with the majority of reports related to minor skin irritation, battery overheating, or device retention issues (e.g., devices becoming stuck in the ear canal). This peer-reviewed evidence reinforces the FDA's decision to establish the 510(k)-exempt OTC pathway, confirming that the air-conduction category carries a low inherent risk profile.

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Actionable Market Access Playbook for Manufacturers

For manufacturers bringing an OTC hearing aid to the US market, this regulatory teardown translates to three strategic recommendations:

1. Optimize the 510(k)-Exempt Pathway (QUF)

For rapid market entry, manufacturers should design their initial product to meet the Class I 510(k)-exempt criteria under product code QUF.

Ensure the device utilizes preset, user-selectable acoustic profiles rather than dynamic self-fitting algorithms, and keep the maximum output strictly below 111 dB SPL (or 117 dB SPL with active compression). By avoiding wireless features that trigger 510(k) review, manufacturers can launch products within weeks of completing design transfer.

2. Prepare a Robust Usability File for Self-Fitting Systems (QUH)

If your product roadmap includes a self-fitting app (code QUH), allocate sufficient budget and time for a clinical usability study.

The 510(k) submission must demonstrate that a lay user can successfully perform the in-app hearing test, interpret the results, and achieve a safe fitting without professional assistance. Focus on developing intuitive user interfaces and clear error-handling protocols for users with varying levels of technical literacy.

3. Establish a Consumer-Facing Post-Market Reporting Portal

Because consumer buyers rarely submit formal MDRs, manufacturers must build active post-market surveillance systems.

Integrate a simple feedback mechanism into the mobile app to capture complaints, device failures, or adverse events (e.g., skin irritation or ear canal trauma). By proactively tracking these events, manufacturers can comply with FDA reporting requirements and generate the post-market data needed to support future submissions.

4. Leverage Related Regulatory Teardowns

When developing your post-market quality system, draw lessons from other consumer-facing or cleared device categories. For example, reviewing the dermal filler approvals and MAUDE adverse-event analysis provides valuable insights into how the FDA monitors direct-to-consumer clinical risks, helping you structure your post-market surveillance programs.

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Frequently Asked Questions (FAQs)

Is an OTC hearing aid a 510(k)-exempt device?

It depends on the product code and technology. Basic, preset air-conduction hearing aids under product code QUF are Class I and 510(k)-exempt, meaning they do not require FDA clearance before marketing. However, wireless preset devices under code QUG and self-fitting wireless devices under code QUH are Class II and require 510(k) clearance.

What is the difference between an OTC hearing aid and a PSAP?

An OTC hearing aid is a regulated medical device intended to compensate for mild-to-moderate hearing impairment in adults. A Personal Sound Amplification Product (PSAP, product code RHO) is a consumer electronic product intended for non-hearing-impaired users to amplify environmental sounds in specific settings (e.g., bird watching). PSAPs cannot be marketed or labeled as treatments for hearing loss.

Which product code should I use for a self-fitting OTC hearing aid?

A self-fitting OTC hearing aid that utilizes software (such as an app-based hearing test) to program the device's acoustic parameters must be listed under product code QUH (Class II, self-fitting wireless OTC). This requires a 510(k) submission with clinical usability data demonstrating that the user can safely and effectively program the device without professional assistance.

Do OTC hearing aids generate MAUDE adverse-event reports?

Historically, OTC hearing aids (QUF/QUG/QUH) have generated almost no adverse-event reports in the MAUDE database. MAUDE reports for hearing devices are dominated by surgical bone-conduction implants (codes PFO and MAH), which represent 71.5% of all reports. Air-conduction devices are low-risk, and malfunctions are typically handled as commercial returns rather than formal medical device reports.

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Sources

1. FDA OTC Hearing Aid Final Rule (87 FR 50698): https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids
2. FDA OTC Hearing Aids Consumer Guide: https://www.fda.gov/medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know
3. FDA Product Classification Database — QUF: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=QUF
4. FDA Guidance on Hearing Aids and PSAPs: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-requirements-hearing-aid-devices-and-personal-sound-amplification-products
5. Hearing Industries Association (HIA) OTC Resources: https://www.betterhearing.org/policy-research/otc-hearing-aids
6. Hyman, Phelps & McNamara FDA Law Blog — One Year of OTC Hearing Aids: https://www.thefdalawblog.com/2023/11/do-you-hear-what-i-hear-one-year-of-otc-hearing-aids
7. Lu Q et al., Review of Reported Adverse Events Associated With Prescription Hearing Aids in MAUDE, Cureus 2025;17(1):e76737 (PMID 39897269, PMCID PMC11784808): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11784808/
8. Borderline Product Classifications: borderline product classification teardown
9. FDA Product Code Guide: FDA product code guide
10. FDA Device Classification Guide: FDA device classification guide