Part 874 Subpart D—Prosthetic Devices
FDA submissions for Part 874 Subpart D—Prosthetic Devices in the Ear, Nose, Throat (EN) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 874.3300–874.3950
CFR Part: 874
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 874.3300 | 1 | 1367 |
| LDG | Kit, Earmold, Impression | 874.3300 | 1 | 2 |
| LRB | Face Plate Hearing Aid | 874.3300 | 1 | 24 |
| QUF | Hearing Aid, Air-Conduction, Over The Counter | 874.3300 | 1 | 0 |
| LXB | Hearing Aid, Bone Conduction | 874.3302 | 2 | 49 |
| MAH | Hearing Aid, Bone Conduction, Implanted | 874.3302 | 2 | 11 |
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription | 874.3305 | 2 | 1 |
| QUG | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | 874.3305 | 2 | 0 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 874.3310 | 2 | 46 |
| PLK | Tympanic Membrane Direct Contact Hearing Aid | 874.3315 | 2 | 3 |
| EPF | Hearing Aid, Group And Auditory Trainer | 874.3320 | 2 | 32 |
| LZI | Device, Assistive Listening | 874.3320 | 2 | 7 |
| QDD | Self-Fitting Air-Conduction Hearing Aid, Prescription | 874.3325 | 2 | 7 |
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter | 874.3325 | 2 | 9 |
| KHL | Hearing Aid, Master | 874.3330 | 2 | 7 |
| SCR | Air-Conduction Hearing Aid Software | 874.3335 | 2 | 3 |
| PFO | Active Implantable Bone Conduction Hearing System | 874.3340 | 2 | 11 |
| ESE | Larynx, Artificial (Battery-Powered) | 874.3375 | 1 | 13 |
| KLW | Masker, Tinnitus | 874.3400 | 2 | 76 |
| QVN | Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus | 874.3410 | 2 | 1 |
| ETC | Mold, Middle-Ear | 874.3430 | 2 | 1 |
| ETB | Prosthesis, Partial Ossicular Replacement | 874.3450 | 2 | 74 |
| LBM | Porous Polyethylene Ossicular Replacement | 874.3450 | 2 | 2 |
| LBP | Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material | 874.3450 | 2 | 0 |
| ETA | Replacement, Ossicular Prosthesis, Total | 874.3495 | 2 | 39 |
| LBN | Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene | 874.3495 | 2 | 1 |
| JXS | Block, Cutting, Ent, Sterile | 874.3540 | 1 | 2 |
| JXT | Crimper, Wire, Ent, Sterile | 874.3540 | 1 | 0 |
| JXW | Die, Wire Bending, Ent, Sterile | 874.3540 | 1 | 0 |
| JXX | Forceps, Wire Closure, Ent, Sterile | 874.3540 | 1 | 0 |
| JXY | Jig, Piston Cutting, Ent, Sterile | 874.3540 | 1 | 0 |
| JXZ | Punch, Gelfoam, Sterile | 874.3540 | 1 | 0 |
| JYA | Scissors, Wire Cutting, Ent, Sterile | 874.3540 | 1 | 0 |
| JYB | Vise, Ossicular Finger, Sterile | 874.3540 | 1 | 0 |
| LRE | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile | 874.3540 | 1 | 0 |
| NNN | Crimper, Wire, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNO | Jig, Piston Cutting, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNP | Die, Wire Bending, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNQ | Forceps, Wire Closure, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNR | Block, Cutting, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNS | Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile | 874.3540 | 1 | 0 |
| NNT | Punch, Gelfoam, Non-Sterile | 874.3540 | 1 | 0 |
| NNU | Scissors, Wire Cutting, Ent, Non-Sterile | 874.3540 | 1 | 0 |
| NNV | Vise, Ossicular Finger, Non-Sterile | 874.3540 | 1 | 0 |
| ESH | Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane | 874.3620 | 2 | 1 |
| FWN | Prosthesis, Larynx (Stents And Keels) | 874.3620 | 2 | 10 |
| JOF | Polymer, Ent Synthetic, Porous Polyethylene | 874.3620 | 2 | 6 |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 874.3620 | 2 | 33 |
| MIB | Elastomer, Silicone Block | 874.3620 | 2 | 45 |
| MIC | Implant, Muscle, Pectoralis | 874.3620 | 2 | 8 |
| MIX | System, Vocal Cord Medialization | 874.3620 | 2 | 17 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 874.3620 | 2 | 15 |
| JAZ | Prosthesis, Facial, Mandibular Implant | 874.3695 | 2 | 2 |
| EWL | Prosthesis, Laryngeal (Taub) | 874.3730 | 2 | 40 |
| MCK | Device, Voice Amplification | 874.3730 | 2 | 0 |
| ESX | Tack, Sacculotomy (Cody Tack) | 874.3760 | 2 | 1 |
| ESZ | Tube, Shunt, Endolymphatic | 874.3820 | 2 | 4 |
| KLZ | Tube, Shunt, Endolymphatic With Valve | 874.3850 | 2 | 1 |
| ETD | Tube, Tympanostomy | 874.3880 | 2 | 115 |
| LBL | Tube, Tympanostomy, Porous Polyethylene | 874.3880 | 2 | 1 |
| OGS | Myringotomy Procedure Kit | 874.3880 | 2 | 0 |
| LWF | Dilator, Nasal | 874.3900 | 1 | 20 |
| KQL | Tube, Tympanostomy With Semi-Permeable Membrane | 874.3930 | 2 | 0 |
| NIX | Hearing Aid, Air Conduction, Transcutaneous System | 874.3950 | 2 | 2 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); | MED-EL Elektromedizinische Geräte GmbH | Apr 3, 2026 |
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 | MED-EL Elektromedizinische Geräte GmbH | Apr 3, 2026 |
| K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) | MED-EL Elektromedizinische Geräte GmbH | Apr 3, 2026 |
| K251790 | SeptAlign | Spirair, Inc. | Jan 16, 2026 |
| K251208 | Tuned Self-Fitting Mobile App | Tuned , Ltd. | Sep 26, 2025 |
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | Cochlear | May 29, 2025 |
| K250256 | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) | Aventamed Dac | Apr 28, 2025 |
| K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | Apr 25, 2025 |
| K243150 | Nuance Audio Hearing Aid Software | Luxottica Group S.P.A. | Jan 31, 2025 |
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | Jan 17, 2025 |
| K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | Jan 17, 2025 |
| K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis | MED-EL Elektromedizinische Geräte GmbH | Jan 17, 2025 |
| K240763 | FirstFit Surgical Kit | Freudenberg Medical, LLC | Dec 18, 2024 |
| DEN230081 | Hearing Aid Feature (HAF) | Apple, Inc. | Sep 12, 2024 |
| K241150 | MISTI Silicone Implant | Keosan Trading Co. | Jul 24, 2024 |
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | Oticon Medical AB | Jul 10, 2024 |
| K232646 | Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) | Cook Biotech Incorporated | May 24, 2024 |
| K232702 | Solo+ Tympanostomy Tube Device (TTD) | Aventamed Dac | May 20, 2024 |
| K240919 | Silk Voice (SMI-04) | Sofregen Medical | May 3, 2024 |
| K240155 | Cochlear Osia System | Cochlear Americas | Apr 18, 2024 |
| K232999 | Lyric4 Hearing Aid | Sonova AG | Apr 11, 2024 |
| K233569 | SeptAlign | Spirair, Inc. | Mar 22, 2024 |
| K233747 | Concha Sol Hearing Aids (CL-1001) | Concha Labs | Mar 15, 2024 |
| K233435 | Peace N Quiet (0.7.0) | Pnq Health | Feb 27, 2024 |
| K233658 | Biowy Tym Tube (TT) | Biowy Corporation | Feb 16, 2024 |
| K233464 | WSA Self-Fitting Hearing Aid Gen 2 | Wsaud A/S | Feb 9, 2024 |
| K232059 | Tympanostomy Tubes | Grace Medical, Inc. | Nov 24, 2023 |
| K231550 | Sontro® OTC Hearing Aids (AI) | Soundwave Hearing, LLC | Oct 26, 2023 |
| K223911 | Lumen 155-SF | Intricon Corporation | Oct 17, 2023 |
| K221052 | Self-Fitting hearing aids | Huizhou Jinghao Medical Technology Co., Ltd. | Sep 25, 2023 |
| K223848 | Intrisound Tuned Lumen® 155 Hearing Aids | Tuned , Ltd. | Sep 8, 2023 |
| K231204 | Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App | Cochlear | Aug 18, 2023 |
| K223167 | Spirair Nasal Septal Strap | Spirair, Inc. | Aug 17, 2023 |
| K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) | Duearity AB | Jun 30, 2023 |
| K230538 | All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid | Sonova AG | Jun 16, 2023 |
| K223137 | Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application | Hearx SA (Pty) , Ltd. | Mar 14, 2023 |
| DEN210033 | Lenire Tinnitus Treatment Device | Neuromod Devices Limited | Mar 6, 2023 |
| K223051 | Pre-Formed Silicone Block | International Medical Devices, Inc. | Feb 3, 2023 |
| K221168 | Tinnitogram Signal Generator | Goldenear Company, Inc. | Feb 1, 2023 |
| K221125 | SilentCloud | Aureliym GmbH | Jan 4, 2023 |
| K222748 | ShiNeo Silicone Implant | Shineo Technology Co., Ltd. | Dec 23, 2022 |
| K221698 | Eargo 5 , Eargo 6 | Eargo, Inc. | Dec 21, 2022 |
| K221064 | Nuheara IQbuds 2 PRO Hearing Aid | Nuheara Limited | Oct 30, 2022 |
| K200073 | AugMENTA Penile Implant | Augmenta, LLC | Sep 30, 2022 |
| K220403 | Vibe SF Self-Fitting Hearing Aid | Wsaud A/S | Aug 12, 2022 |
| K220303 | MDHearingAid app, MDHearingAid Smart hearing aids | Mdhearingaid | Aug 4, 2022 |
| K221254 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | Jul 27, 2022 |
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit | Cochlear Americas | Jul 27, 2022 |
| K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | May 13, 2022 |
| K210411 | PosiSep EAR Fragmentable Ear Dressing | Hemostasis, LLC | May 5, 2022 |
| K213424 | Jabra Enhance Plus | GN Hearing A/S | Jan 19, 2022 |
| K212609 | BHA100 Series Braun Clear Hearing Aid | Kaz USA, Inc., A Helen of Troy Company | Jan 5, 2022 |
| K213733 | Ponto 5 SuperPower | Oticon Medical AB | Dec 16, 2021 |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | Cochlear Americas | Sep 29, 2021 |
| K211640 | Ponto 5 Mini | Oticon Medical AB | Aug 10, 2021 |
| K211008 | Bose SoundControl Hearing Aids | Bose Corporation | May 5, 2021 |
| K203807 | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Oticon Medical AB | Mar 3, 2021 |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | Cochlear Americas | Feb 23, 2021 |
| K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) | Med-El Elektromedizinische Geraete GmbH | Oct 9, 2020 |
| K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | Med-El Elektromedizinische Geraete GmbH | Jul 29, 2020 |
| K193392 | BioSiCar Silicone Implant | Metalware Technology Corp. | Jul 20, 2020 |
| K201370 | Multiflex Tinnitus Technology | Starkey Laboratories, Inc. | Jun 19, 2020 |
| K200952 | Hummingbird Tympanostomy Tube System | Preceptis Medical, Inc. | Jun 5, 2020 |
| K200532 | StarPore | Anatomics Pty, Ltd. | Jun 2, 2020 |
| K193303 | Tinnitus Sound Generator Module | GN Hearing A/S | Feb 20, 2020 |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments | Cochlear Americas | Nov 15, 2019 |
| K192661 | LATERA Absorbable Nasal Implant System | Entellus Medical, Inc. (Aka Stryker Ent) | Nov 10, 2019 |
| K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) | Med-El Elektromedizinische Geraete GmbH | Sep 18, 2019 |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments | Cochlear Americas | Jul 3, 2019 |
| K190540 | Ponto 4 | Oticon Medical AB | May 2, 2019 |
| K183015 | PuraSinus | 3-D Matrix, Inc. | Apr 12, 2019 |
| K183373 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | Mar 7, 2019 |
| K182480 | Earlens Contact Hearing Aid | Earlens Corporation | Jan 25, 2019 |
| K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | Jan 23, 2019 |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas | Dec 19, 2018 |
| K180495 | Tinnitus Sound Generator Module | GN Hearing A/S | Nov 30, 2018 |
| K180631 | Silk Voice | Sofregen Medical, Inc. | Nov 8, 2018 |
| DEN180026 | Bose Hearing Aid | Bose Corporation | Oct 5, 2018 |
| K181219 | OptiPillows EPAP Mask | Cpapnea Medical Supply | Aug 3, 2018 |
| DEN170009 | Bonebridge | Med-El Elektromedizinische Geraete GmbH | Jul 20, 2018 |
| K181586 | Tinnitus Sound Generator Module | GN Hearing A/S | Jul 13, 2018 |
| K172460 | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | Apr 27, 2018 |
| K171851 | SOFTXIL | Bistool | Mar 16, 2018 |
| K171037 | PoreStar Patient Specific Implant | Anatomics Pty, Ltd. | Dec 27, 2017 |
| K171243 | audifon Tinnitus-Module | Audiofon USA, Inc. | Oct 19, 2017 |
| K171239 | TULA Tube Delivery System | Tusker Medical | Jun 28, 2017 |
| K171088 | Cochlear Baha SoundArc | Cochlear Americas | Jun 7, 2017 |
| K163094 | TinniLogic Mobile Tinnitus Management Device | Jiangsu Betterlife Medical Co., Ltd. | May 17, 2017 |
| K162624 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | Feb 1, 2017 |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | Sep 29, 2016 |
| K161562 | Sound Options Tinnitus Treatment | Sound Options Tinnitus Treatments, Inc. | Sep 28, 2016 |
| K161331 | HyperSound Tinnitus Module | Turtle Beach Corporation | Aug 23, 2016 |
| K161191 | Latera Absorbable Nasal Implant | Spirox, Inc. | Jun 23, 2016 |
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | Jun 16, 2016 |
| K161123 | Baha 5 Power Sound Processor | Cochlear Americas | May 20, 2016 |
| K161000 | Biodesign Otologic Repair Graft | Cook Biotech Incorporated | May 11, 2016 |
| K153634 | Wireless Earlens Light Driven Hearing Aid | Earlens Corporation | Apr 6, 2016 |
| K153245 | Baha 5 Super Power Sound Processor | Cochlear Americas | Mar 2, 2016 |
| K152820 | Ponto Bone Anchored Hearing System | Oticon Medical AB | Jan 22, 2016 |
| K151558 | Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System | Neurotherapies Reset GmbH | Jan 20, 2016 |
