--- title: "Hearing Devices, Definition | MedTech Terms" description: "Air-conduction and bone-conduction hearing aids, OTC hearing aids, and cochlear implants, spanning Class I, II, and III pathways." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/hearing-devices#term", "name": "Hearing Devices", "alternateName": [ "Hearing aids", "Audiology devices" ], "description": "The hearing-devices segment covers prescription air-conduction hearing aids, the FDA-created OTC hearing aid category (effective October 2022 under 21 CFR 800.30), bone-anchored hearing systems, and cochlear implants. The 2022 OTC rule fundamentally restructured the consumer end of the market by allowing direct-to-consumer sale of mild-to-moderate hearing-loss devices to adults without an audiologist visit.", "url": "https://medtechterms.com/terms/hearing-devices", "termCode": "hearing-devices", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/hearing-devices#article", "headline": "Hearing Devices", "description": "Air-conduction and bone-conduction hearing aids, OTC hearing aids, and cochlear implants, spanning Class I, II, and III pathways.", "url": "https://medtechterms.com/terms/hearing-devices", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/hearing-devices" }, "about": { "@id": "https://medtechterms.com/terms/hearing-devices#term" }, "articleSection": "Market Segments", "inLanguage": "en", "keywords": "Hearing Devices, Hearing aids, Audiology devices, Market Segments, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-05-09", "dateModified": "2026-05-09", "citation": [ { "@type": "CreativeWork", "name": "FDA, OTC Hearing Aids Final Rule", "url": "https://www.fda.gov/medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know", "publisher": { "@type": "Organization", "name": "FDA" } }, { "@type": "CreativeWork", "name": "MedTech Europe - Facts & Figures", "url": "https://www.medtecheurope.org/datahub/", "publisher": { "@type": "Organization", "name": "MedTech Europe" } }, { "@type": "CreativeWork", "name": "MedTech Dive", "url": "https://www.medtechdive.com/", "publisher": { "@type": "Organization", "name": "MedTech Dive" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/510k#term", "name": "510(k) Premarket Notification", "alternateName": "510(k)", "url": "https://medtechterms.com/terms/510k" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pma#term", "name": "Premarket Approval", "alternateName": "PMA", "url": "https://medtechterms.com/terms/pma" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Market Segments", "item": "https://medtechterms.com/terms?cat=Market%20Segments" }, { "@type": "ListItem", "position": 4, "name": "Hearing Devices", "item": "https://medtechterms.com/terms/hearing-devices" } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Market Segments](/terms?cat=Market%20Segments) 6. / 7. Hearing Devices [All terms](/terms) Market Segments [Strategic Landscape](/ecosystems/strategic-landscape) # Hearing Devices Air-conduction and bone-conduction hearing aids, OTC hearing aids, and cochlear implants, spanning Class I, II, and III pathways. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 9, 2026 ## Definition The hearing-devices segment covers prescription air-conduction hearing aids, the FDA-created OTC hearing aid category (effective October 2022 under 21 CFR 800.30), bone-anchored hearing systems, and cochlear implants. The 2022 OTC rule fundamentally restructured the consumer end of the market by allowing direct-to-consumer sale of mild-to-moderate hearing-loss devices to adults without an audiologist visit. What the regulation says 21 CFR 800.30 (OTC hearing aids), 21 CFR 874.3300 (prescription hearing aids), and 21 CFR 874.3450 (bone-conduction). Cochlear implants are Class III [PMA](/terms/pma) devices under product code MCM. ## What this means in practice OTC hearing aids brought new entrants (Apple AirPods Pro hearing-aid feature, Sony, Bose) and price compression on traditional prescription products. Insurance coverage remains uneven; Medicare does not cover most hearing aids. Common pitfalls - • Marketing personal sound amplification products (PSAPs) with hearing-loss claims, that triggers FDA hearing-aid regulation. - • Forgetting that pediatric hearing aids remain prescription-only under the OTC rule. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory Premarket Approval(PMA) FDA's most stringent device marketing application, required for high-risk Class III devices. ](/terms/pma) ### More in Market Segments · Same category [ Market Segments Aesthetic & Energy-Based Devices Lasers, RF, ultrasound, cryolipolysis, and IPL systems used for medical and cosmetic indications, body contouring, hair removal, skin tightening, vascular lesions. ](/terms/aesthetics-energy-devices)[ Market Segments AI Imaging Software Software that analyzes medical images to triage, detect, or quantify disease. ](/terms/ai-imaging)[ Market Segments Cardiac Rhythm Management(CRM) Implantable and external devices that monitor and treat cardiac arrhythmias, pacemakers, ICDs, CRT devices, and insertable cardiac monitors. ](/terms/cardiac-rhythm-management)[ Market Segments Cardiovascular Devices Devices for diagnosing, monitoring, or treating cardiovascular disease. ](/terms/cardiovascular) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Strategic Landscape](/ecosystems/strategic-landscape) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 FDA· 1 MedTech Europe· 1 MedTech Dive· 1 1. [1 FDA, OTC Hearing Aids Final Rule Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know) 2. [2 MedTech Europe - Facts & Figures Verified MedTech Europe · medtecheurope.org ](https://www.medtecheurope.org/datahub/) 3. [3 MedTech Dive Verified MedTech Dive · medtechdive.com ](https://www.medtechdive.com/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Building a connected device in this segment? Blue Goat Cyber specializes in MedTech cybersecurity across imaging, cardiac, IVD, surgical, and other connected segments. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Market Segments Sources 3 Updated 5/9/2026 [Compare with another term](/compare?a=hearing-devices) Learn in 60 seconds Card Lesson Quiz Air-conduction and bone-conduction hearing aids, OTC hearing aids, and cochlear implants, spanning Class I, II, and III pathways. - · OTC hearing aids brought new entrants (Apple AirPods Pro hearing-aid feature, Sony, Bose) and price compression on traditional prescription products. - · Insurance coverage remains uneven; Medicare does not cover most hearing aids. - · The 2022 OTC rule fundamentally restructured the consumer end of the market by allowing direct-to-consumer sale of mild-to-moderate hearing-loss devices to adults without an audiologist visit. Remember this Watch out: Marketing personal sound amplification products (PSAPs) with hearing-loss claims, that triggers FDA hearing-aid regulation. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [Premarket Approval(PMA) ](/terms/pma) You may also need Auto-suggested from Market Segments and shared keywords. - [Cardiac Rhythm Management(CRM) ](/terms/cardiac-rhythm-management) - [ENT Devices ](/terms/ent-devices) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [Dental Devices ](/terms/dental-devices) - [Endoscopy Devices ](/terms/endoscopy-devices) - [Urology Devices ](/terms/urology-devices) [All Market Segments terms](/terms?cat=Market%20Segments) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)