Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- EPFHearing Aid, Group And Auditory Trainer2Product Code
- NEACement, Ear, Nose And Throat2Product Code
- ESDHearing Aid, Air Conduction1Product Code
- ESELarynx, Artificial (Battery-Powered)1Product Code
- ESHPolymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane2Product Code
- ESXTack, Sacculotomy (Cody Tack)2Product Code
- ESZTube, Shunt, Endolymphatic2Product Code
- ETAReplacement, Ossicular Prosthesis, Total2Product Code
- ETBProsthesis, Partial Ossicular Replacement2Product Code
- ETCMold, Middle-Ear2Product Code
- ETDTube, Tympanostomy2Product Code
- ETWCalibrator, Hearing Aid / Earphone And Analysis Systems2Product Code
- EWLProsthesis, Laryngeal (Taub)2Product Code
- FWNProsthesis, Larynx (Stents And Keels)2Product Code
- JAZProsthesis, Facial, Mandibular Implant2Product Code
- JOFPolymer, Ent Synthetic, Porous Polyethylene2Product Code
- JXSBlock, Cutting, Ent, Sterile1Product Code
- JXTCrimper, Wire, Ent, Sterile1Product Code
- JXWDie, Wire Bending, Ent, Sterile1Product Code
- JXXForceps, Wire Closure, Ent, Sterile1Product Code
- JXYJig, Piston Cutting, Ent, Sterile1Product Code
- JXZPunch, Gelfoam, Sterile1Product Code
- JYAScissors, Wire Cutting, Ent, Sterile1Product Code
- JYBVise, Ossicular Finger, Sterile1Product Code
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)2Product Code
- KHLHearing Aid, Master2Product Code
- KLWMasker, Tinnitus2Product Code
- K233435Peace N Quiet (0.7.0)2Cleared 510(K)
- K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)2Cleared 510(K)
- K221168Tinnitogram Signal Generator2Cleared 510(K)
- K221125SilentCloud2Cleared 510(K)
- K201370Multiflex Tinnitus Technology2Cleared 510(K)
- K193303Tinnitus Sound Generator Module2Cleared 510(K)
- K180495Tinnitus Sound Generator Module2Cleared 510(K)
- K181586Tinnitus Sound Generator Module2Cleared 510(K)
- K171243audifon Tinnitus-Module2Cleared 510(K)
- K163094TinniLogic Mobile Tinnitus Management Device2Cleared 510(K)
- K161562Sound Options Tinnitus Treatment2Cleared 510(K)
- K161331HyperSound Tinnitus Module2Cleared 510(K)
- K151558Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System2Cleared 510(K)
- K151719REVE1342Cleared 510(K)
- K150014Serenity2Cleared 510(K)
- K150171Tinnitus Sound Generator Module2Cleared 510(K)
- K150065SoundCure Serenade Tinnitus Treatment System2Cleared 510(K)
- K140845LEVO TINNITUS MASKING SOFTWARE DEVICE2Cleared 510(K)
- K132965SOLACE SOUND GENERATORS2Cleared 510(K)
- K133308TINNITUS SOUNDSUPPORT2Cleared 510(K)
- K130937WAVE 2G, SOUL2Cleared 510(K)
- K130514AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT2Cleared 510(K)
- K130417AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S2Cleared 510(K)
- K130494UNITRON TINNITUS MASKER FEATURE2Cleared 510(K)
- K123450PHONAK TINNITUS BALANCE2Cleared 510(K)
- K122876MULTIFLEX TINNITUS TECHNOLOGY2Cleared 510(K)
- K112752TINNITUS THERAPY SYSTEM ANM T30 CR2Cleared 510(K)
- K111293SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM2Cleared 510(K)
- K110973IE-ZEN (IN CLEAR SERIES HEARING AID)2Cleared 510(K)
- K110932TINNITUS SOUND GENERATOR MODULE2Cleared 510(K)
- K093715EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE2Cleared 510(K)
- K091552SWITCH TRT2Cleared 510(K)
- K083488JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT2Cleared 510(K)
- K080955ZEN PROGRAM (MIND 440 HEARING AID)2Cleared 510(K)
- K073636TINNITUS SOUND GENERATOR MODULE2Cleared 510(K)
- K070599CUSTOMIZED SOUND THERAPY (CST)2Cleared 510(K)
- K070648THE INHIBITOR, MODEL 0012Cleared 510(K)
- K061459TRANQUIL TRI-BTE2Cleared 510(K)
- K061111TINNITUS PHASE-OUT2Cleared 510(K)
- K043274NEUROMONICS TINNITUS TREATMENT2Cleared 510(K)
- K041302REFUGE SOUND GENERATOR2Cleared 510(K)
- K040330QUIESCENCE2Cleared 510(K)
- K030180CRESCENT TINNITUS RETAINING SOUND GENERATOR2Cleared 510(K)
- K031624TINNITUS RX2Cleared 510(K)
- K030791ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)2Cleared 510(K)
- K021202ULTRAQUIET2Cleared 510(K)
- K013827TST - SUPPRESSOR MODEL #10002Cleared 510(K)
- K013253HISONIC-TRD TINNITUS RELIEF DEVICE2Cleared 510(K)
- K011364CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)2Cleared 510(K)
- K011366CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)2Cleared 510(K)
- K003559TCI (TINNITUS CONTROL INSTRUMENT)2Cleared 510(K)
- K982451TTCGHI-T AND TTCTN3-T-T2Cleared 510(K)
- K982432PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-2Cleared 510(K)
- K984243TELEX TINNITUS-COMPANION2Cleared 510(K)
- K981704AUREX-32Cleared 510(K)
- K974501DIGITAL TINNITUS MASKING SYSTEM2Cleared 510(K)
- K964216STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER2Cleared 510(K)
- K963995STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER2Cleared 510(K)
- K963838STARKEY TM AIR CONDUCTION TINNITUS MASKER2Cleared 510(K)
- K941834AUDITORY CASSETTE2Cleared 510(K)
- K940567MODEL#1550 MARSONA(R) TINNITUS MASKER2Cleared 510(K)
- K924991MICRO MASKER2Cleared 510(K)
- K922572321Q MINIMUM ENERGY TINNITUS SUPPRESSOR2Cleared 510(K)
- K802750NUVOX BEDSIDE TINNITUS MASKER2Cleared 510(K)
- K802234BEDSIDE TINNITUS MASKER #15002Cleared 510(K)
- K800702TA-641 TINNITUS INSTRUMENT2Cleared 510(K)
- K800784MINUET MASKER; JUBILEE MASKER2Cleared 510(K)
- K800701T-570 TINNITUS MASKER2Cleared 510(K)
- K791790MODEL TM5 BEHIND EAR TINNITUS MASKER2Cleared 510(K)
- K791142HEARING AID, MODEL MA-12Cleared 510(K)
- K791071MODEL MA3 BEHIND-THE-EAR MASKER/HEARING2Cleared 510(K)
- K790190TINNITUS MASKERS MODEL S5842Cleared 510(K)
- K781798TINNITUS MASKER2Cleared 510(K)
- K780546BEHIND-THE-EAR MASKING AMPLIFIER,735S2Cleared 510(K)
- K771769TINNITUS MASKERS, MODELS S564&S5742Cleared 510(K)
- K770938TINNITUS AID, MODEL S2442Cleared 510(K)
- KLZTube, Shunt, Endolymphatic With Valve2Product Code
- KQLTube, Tympanostomy With Semi-Permeable Membrane2Product Code
- LBLTube, Tympanostomy, Porous Polyethylene2Product Code
- LBMPorous Polyethylene Ossicular Replacement2Product Code
- LBNReplacement, Total Ossicular, Prosthesis, Porous, Polyethylene2Product Code
- LBPReplacement, Ossicular (Stapes) Using Absorbable Gelatin Material2Product Code
- LDGKit, Earmold, Impression1Product Code
- LRBFace Plate Hearing Aid1Product Code
- LREInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile1Product Code
- LWFDilator, Nasal1Product Code
- LXBHearing Aid, Bone Conduction2Product Code
- LZIDevice, Assistive Listening2Product Code
- MAHHearing Aid, Bone Conduction, Implanted2Product Code
- MCKDevice, Voice Amplification2Product Code
- MIXSystem, Vocal Cord Medialization2Product Code
- NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable2Product Code
- NIXHearing Aid, Air Conduction, Transcutaneous System2Product Code
- NNNCrimper, Wire, Ent, Non-Sterile1Product Code
- NNOJig, Piston Cutting, Ent, Non-Sterile1Product Code
- NNPDie, Wire Bending, Ent, Non-Sterile1Product Code
- NNQForceps, Wire Closure, Ent, Non-Sterile1Product Code
- NNRBlock, Cutting, Ent, Non-Sterile1Product Code
- NNSInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile1Product Code
- NNTPunch, Gelfoam, Non-Sterile1Product Code
- NNUScissors, Wire Cutting, Ent, Non-Sterile1Product Code
- NNVVise, Ossicular Finger, Non-Sterile1Product Code
- OGSMyringotomy Procedure Kit2Product Code
- OSMHearing Aid, Air Conduction With Wireless Technology2Product Code
- PFOActive Implantable Bone Conduction Hearing System2Product Code
- PLKTympanic Membrane Direct Contact Hearing Aid2Product Code
- QDDSelf-Fitting Air-Conduction Hearing Aid2Product Code
- QUFHearing Aid, Air-Conduction, Over The Counter1Product Code
- QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter2Product Code
- QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ZEN PROGRAM (MIND 440 HEARING AID)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K080955
- 510(k) Type
- Traditional
- Applicant
- WIDEX HEARING AID CO., INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/27/2008
- Days to Decision
- 85 days
- Submission Type
- Summary