Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3300](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3300) → ESD — Hearing Aid, Air-Conduction, Prescription # ESD · Hearing Aid, Air-Conduction, Prescription _Ear, Nose, Throat · 21 CFR 874.3300 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD ## Overview - **Product Code:** ESD - **Device Name:** Hearing Aid, Air-Conduction, Prescription - **Regulation:** [21 CFR 874.3300](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3300) - **Device Class:** 1 - **Review Panel:** [Ear, Nose, Throat](/submissions/EN) ## Identification An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively. ## Classification Rationale Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9. ## Recent Cleared Devices (20 of 1367) Showing 20 most recent of 1367 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K232999](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K232999.md) | Lyric4 Hearing Aid | Sonova AG | Apr 11, 2024 | SESE | | [K130790](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K130790.md) | LYRIC2 | Phonak, LLC | Jun 27, 2013 | SESE | | [K081136](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K081136.md) | LYRIC HEARING AID | Insound Medical, Inc. | May 8, 2008 | SESE | | [K021867](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K021867.md) | INSOUND XT SERIES HEARING AID | Insound Medical, Inc. | Nov 19, 2002 | SESE | | [K003558](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K003558.md) | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | Apr 24, 2001 | SESE | | [K984518](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K984518.md) | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL | Sonic Innovations, Inc. | Mar 12, 1999 | SESE | | [K974751](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K974751.md) | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | General Hearing Instruments, Inc. | Mar 6, 1998 | SESE | | [K974242](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K974242.md) | ARGOSY PROGRAMMABLE ONQUE | Argosy Electronics | Jan 20, 1998 | SESE | | [K973880](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K973880.md) | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | Sonix Technologies, Inc. | Jan 12, 1998 | SESE | | [K974211](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K974211.md) | OPUS 2 - FULL CONCHA SERIES - ITE | Bernafon-Maico, Inc. | Dec 15, 1997 | SESE | | [K974152](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K974152.md) | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | Bernafon-Maico, Inc. | Dec 15, 1997 | SESE | | [K974069](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K974069.md) | OPUS 2 - CANAL SERIES (ITC) | Bernafon-Maico, Inc. | Dec 15, 1997 | SESE | | [K974340](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K974340.md) | UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE | Unitron Industries, Inc. | Dec 12, 1997 | SESE | | [K974339](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K974339.md) | UNITRON MODEL SOUND F/XD PROGRAMMABLE | Unitron Industries, Inc. | Dec 12, 1997 | SESE | | [K974338](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K974338.md) | UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) | Unitron Industries, Inc. | Dec 12, 1997 | SESE | | [K974257](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K974257.md) | RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) | Resound Corp. | Dec 12, 1997 | SESE | | [K974129](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K974129.md) | HI-69E, HI-69N, HI-69P | Rockwin Corp. | Dec 12, 1997 | SESE | | [K974081](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K974081.md) | RESOUND STEALTH CIC | Resound Corp. | Dec 12, 1997 | SESE | | [K973927](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K973927.md) | HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL | Hyunjae Corp. | Dec 11, 1997 | SESE | | [K973861](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD/K973861.md) | FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48 | Magnatone Hearing Aid Corp. | Nov 19, 1997 | SESE | ## Top Applicants - Unitron Industries, Inc. — 69 clearances - Miracle-Ear, Inc. — 64 clearances - Electone, Inc. — 63 clearances - Oticon Corp. — 54 clearances - Widex Hearing Aid Co., Inc. — 51 clearances --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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