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- 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
- 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
- K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand2Cleared 510(K)
- K243041contact forte Alpha2Cleared 510(K)
- K213733Ponto 5 SuperPower2Cleared 510(K)
- K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App2Cleared 510(K)
- K211640Ponto 5 Mini2Cleared 510(K)
- K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App2Cleared 510(K)
- K190540Ponto 42Cleared 510(K)
- K172460ADHEAR System2Cleared 510(K)
- K171088Cochlear Baha SoundArc2Cleared 510(K)
- K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPower2Cleared 510(K)
- K153391Sophono Bone Conduction Systems (S) Configuration and (M) Configuration2Cleared 510(K)
- K161123Baha 5 Power Sound Processor2Cleared 510(K)
- K153245Baha 5 Super Power Sound Processor2Cleared 510(K)
- K150751Cordelle II Sound Processor2Cleared 510(K)
- K142907Baha 5 Sound Processor2Cleared 510(K)
- K132775PONTO PLUS AND PONTO PLUS POWER2Cleared 510(K)
- K132189OTOMAG BONE CONDUCATION HEARING SYSTEM2Cleared 510(K)
- K131240COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT2Cleared 510(K)
- K132278COCHLEAR BAHA 4 SOUND PROCESSOR2Cleared 510(K)
- K123962OTOMAG BONE CONDUCTION HEARING SYSTEM2Cleared 510(K)
- K121793AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON2Cleared 510(K)
- K110831SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL2Cleared 510(K)
- K103594PONTO PRO POWER2Cleared 510(K)
- K102199OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)2Cleared 510(K)
- K110996BAHA 3 POWER SOUND PROCESSOR2Cleared 510(K)
- K100649SOUNDBITE HEARING SYSTEM BY SONITUS2Cleared 510(K)
- K100360BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT2Cleared 510(K)
- K100193OTOMAG BONE CONDUCTION HEARING SYSTEM2Cleared 510(K)
- K090996PONTO PRO2Cleared 510(K)
- K090720COCHLEAR BAHA BP1002Cleared 510(K)
- K082108OBC BONE ANCHORED HEARING AID SYSTEM2Cleared 510(K)
- K081606BAHA INTENSO2Cleared 510(K)
- K062404TRANSEAR BONE CONDUCTION HEARING AID2Cleared 510(K)
- K050653TRANSEAR BONE CONDUCTION HEARING AID2Cleared 510(K)
- K042017BAHA DIVINO2Cleared 510(K)
- K021837BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)2Cleared 510(K)
- K011438BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.2Cleared 510(K)
- K002913HEADBAND FOR BAHA2Cleared 510(K)
- K992872BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II2Cleared 510(K)
- K955713NOBELPHARMA BONE ANCHORED HEARING AID2Cleared 510(K)
- K953872SECOND EAR BONE CONDUCTION HEARING AID2Cleared 510(K)
- K951678HI SONIC 2000 DIGITAL HEARING INSTRUMENT2Cleared 510(K)
- K935701VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F2292Cleared 510(K)
- K884056MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR2Cleared 510(K)
- K881382XOMED AUDIANT BONE CONDUCTOR2Cleared 510(K)
- K875277ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.2Cleared 510(K)
- K872168XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.2Cleared 510(K)
- K861971XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL2Cleared 510(K)
- K855059AUDIANT BONE CONDUCTOR OR A.B.C.2Cleared 510(K)
- 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
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- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
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- PathologyReview Panel
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- UnknownReview Panel
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
- Page Type
- Cleared 510(K)
- 510(k) Number
- K153391
- 510(k) Type
- Traditional
- Applicant
- SOPHONO INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/16/2016
- Days to Decision
- 205 days
- Submission Type
- Summary