FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
EPF
Hearing Aid, Group And Auditory Trainer
2
Product Code
NEA
Cement, Ear, Nose And Throat
2
Product Code
ESD
Hearing Aid, Air Conduction
1
Product Code
ESE
Larynx, Artificial (Battery-Powered)
1
Product Code
ESH
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
2
Product Code
ESX
Tack, Sacculotomy (Cody Tack)
2
Product Code
ESZ
Tube, Shunt, Endolymphatic
2
Product Code
ETA
Replacement, Ossicular Prosthesis, Total
2
Product Code
ETB
Prosthesis, Partial Ossicular Replacement
2
Product Code
ETC
Mold, Middle-Ear
2
Product Code
ETD
Tube, Tympanostomy
2
Product Code
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
2
Product Code
EWL
Prosthesis, Laryngeal (Taub)
2
Product Code
FWN
Prosthesis, Larynx (Stents And Keels)
2
Product Code
JAZ
Prosthesis, Facial, Mandibular Implant
2
Product Code
JOF
Polymer, Ent Synthetic, Porous Polyethylene
2
Product Code
JXS
Block, Cutting, Ent, Sterile
1
Product Code
JXT
Crimper, Wire, Ent, Sterile
1
Product Code
JXW
Die, Wire Bending, Ent, Sterile
1
Product Code
JXX
Forceps, Wire Closure, Ent, Sterile
1
Product Code
JXY
Jig, Piston Cutting, Ent, Sterile
1
Product Code
JXZ
Punch, Gelfoam, Sterile
1
Product Code
JYA
Scissors, Wire Cutting, Ent, Sterile
1
Product Code
JYB
Vise, Ossicular Finger, Sterile
1
Product Code
KHJ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
2
Product Code
KHL
Hearing Aid, Master
2
Product Code
KLW
Masker, Tinnitus
2
Product Code
KLZ
Tube, Shunt, Endolymphatic With Valve
2
Product Code
KQL
Tube, Tympanostomy With Semi-Permeable Membrane
2
Product Code
LBL
Tube, Tympanostomy, Porous Polyethylene
2
Product Code
LBM
Porous Polyethylene Ossicular Replacement
2
Product Code
LBN
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
2
Product Code
LBP
Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
2
Product Code
LDG
Kit, Earmold, Impression
1
Product Code
LRB
Face Plate Hearing Aid
1
Product Code
LRE
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile
1
Product Code
LWF
Dilator, Nasal
1
Product Code
LXB
Hearing Aid, Bone Conduction
2
Product Code
K
21
3733
Ponto 5 SuperPower
2
Cleared 510(K)
K
21
2136
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
2
Cleared 510(K)
K
21
1640
Ponto 5 Mini
2
Cleared 510(K)
K
20
2048
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
2
Cleared 510(K)
K
19
0540
Ponto 4
2
Cleared 510(K)
K
17
2460
ADHEAR System
2
Cleared 510(K)
K
17
1088
Cochlear Baha SoundArc
2
Cleared 510(K)
K
16
1671
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
2
Cleared 510(K)
K
15
3391
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
2
Cleared 510(K)
K
16
1123
Baha 5 Power Sound Processor
2
Cleared 510(K)
K
15
3245
Baha 5 Super Power Sound Processor
2
Cleared 510(K)
K
15
0751
Cordelle II Sound Processor
2
Cleared 510(K)
K
14
2907
Baha 5 Sound Processor
2
Cleared 510(K)
K
13
2775
PONTO PLUS AND PONTO PLUS POWER
2
Cleared 510(K)
K
13
2189
OTOMAG BONE CONDUCATION HEARING SYSTEM
2
Cleared 510(K)
K
13
1240
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
2
Cleared 510(K)
K
13
2278
COCHLEAR BAHA 4 SOUND PROCESSOR
2
Cleared 510(K)
K
12
3962
OTOMAG BONE CONDUCTION HEARING SYSTEM
2
Cleared 510(K)
K
12
1793
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
2
Cleared 510(K)
K
11
0831
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
2
Cleared 510(K)
K
10
3594
PONTO PRO POWER
2
Cleared 510(K)
K
10
2199
OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
2
Cleared 510(K)
K
11
0996
BAHA 3 POWER SOUND PROCESSOR
2
Cleared 510(K)
K
10
0649
SOUNDBITE HEARING SYSTEM BY SONITUS
2
Cleared 510(K)
K
10
0360
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
2
Cleared 510(K)
K
10
0193
OTOMAG BONE CONDUCTION HEARING SYSTEM
2
Cleared 510(K)
K
09
0996
PONTO PRO
2
Cleared 510(K)
K
09
0720
COCHLEAR BAHA BP100
2
Cleared 510(K)
K
08
2108
OBC BONE ANCHORED HEARING AID SYSTEM
2
Cleared 510(K)
K
08
1606
BAHA INTENSO
2
Cleared 510(K)
K
06
2404
TRANSEAR BONE CONDUCTION HEARING AID
2
Cleared 510(K)
K
05
0653
TRANSEAR BONE CONDUCTION HEARING AID
2
Cleared 510(K)
K
04
2017
BAHA DIVINO
2
Cleared 510(K)
K
02
1837
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
2
Cleared 510(K)
K
01
1438
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
2
Cleared 510(K)
K
00
2913
HEADBAND FOR BAHA
2
Cleared 510(K)
K
99
2872
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
2
Cleared 510(K)
K
95
5713
NOBELPHARMA BONE ANCHORED HEARING AID
2
Cleared 510(K)
K
95
3872
SECOND EAR BONE CONDUCTION HEARING AID
2
Cleared 510(K)
K
95
1678
HI SONIC 2000 DIGITAL HEARING INSTRUMENT
2
Cleared 510(K)
K
93
5701
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
2
Cleared 510(K)
K
88
4056
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
2
Cleared 510(K)
K
88
1382
XOMED AUDIANT BONE CONDUCTOR
2
Cleared 510(K)
K
87
5277
ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
2
Cleared 510(K)
K
87
2168
XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.
2
Cleared 510(K)
K
86
1971
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
2
Cleared 510(K)
K
85
5059
AUDIANT BONE CONDUCTOR OR A.B.C.
2
Cleared 510(K)
LZI
Device, Assistive Listening
2
Product Code
MAH
Hearing Aid, Bone Conduction, Implanted
2
Product Code
MCK
Device, Voice Amplification
2
Product Code
MIX
System, Vocal Cord Medialization
2
Product Code
NHB
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
2
Product Code
NIX
Hearing Aid, Air Conduction, Transcutaneous System
2
Product Code
NNN
Crimper, Wire, Ent, Non-Sterile
1
Product Code
NNO
Jig, Piston Cutting, Ent, Non-Sterile
1
Product Code
NNP
Die, Wire Bending, Ent, Non-Sterile
1
Product Code
NNQ
Forceps, Wire Closure, Ent, Non-Sterile
1
Product Code
NNR
Block, Cutting, Ent, Non-Sterile
1
Product Code
NNS
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
1
Product Code
NNT
Punch, Gelfoam, Non-Sterile
1
Product Code
NNU
Scissors, Wire Cutting, Ent, Non-Sterile
1
Product Code
NNV
Vise, Ossicular Finger, Non-Sterile
1
Product Code
OGS
Myringotomy Procedure Kit
2
Product Code
OSM
Hearing Aid, Air Conduction With Wireless Technology
2
Product Code
PFO
Active Implantable Bone Conduction Hearing System
2
Product Code
PLK
Tympanic Membrane Direct Contact Hearing Aid
2
Product Code
QDD
Self-Fitting Air-Conduction Hearing Aid
2
Product Code
QUF
Hearing Aid, Air-Conduction, Over The Counter
1
Product Code
QUG
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
2
Product Code
QUH
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
2
Product Code
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
EN
/
subpart-d—prosthetic-devices
/
LXB
/
K011438
View Source
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011438
510(k) Type
Traditional
Applicant
ENTIFIC MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/23/2001
Days to Decision
74 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
EPF
Hearing Aid, Group And Auditory Trainer
NEA
Cement, Ear, Nose And Throat
ESD
Hearing Aid, Air Conduction
ESE
Larynx, Artificial (Battery-Powered)
ESH
Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
ESX
Tack, Sacculotomy (Cody Tack)
ESZ
Tube, Shunt, Endolymphatic
ETA
Replacement, Ossicular Prosthesis, Total
ETB
Prosthesis, Partial Ossicular Replacement
ETC
Mold, Middle-Ear
ETD
Tube, Tympanostomy
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
EWL
Prosthesis, Laryngeal (Taub)
FWN
Prosthesis, Larynx (Stents And Keels)
JAZ
Prosthesis, Facial, Mandibular Implant
JOF
Polymer, Ent Synthetic, Porous Polyethylene
JXS
Block, Cutting, Ent, Sterile
JXT
Crimper, Wire, Ent, Sterile
JXW
Die, Wire Bending, Ent, Sterile
JXX
Forceps, Wire Closure, Ent, Sterile
JXY
Jig, Piston Cutting, Ent, Sterile
JXZ
Punch, Gelfoam, Sterile
JYA
Scissors, Wire Cutting, Ent, Sterile
JYB
Vise, Ossicular Finger, Sterile
KHJ
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
KHL
Hearing Aid, Master
KLW
Masker, Tinnitus
KLZ
Tube, Shunt, Endolymphatic With Valve
KQL
Tube, Tympanostomy With Semi-Permeable Membrane
LBL
Tube, Tympanostomy, Porous Polyethylene
LBM
Porous Polyethylene Ossicular Replacement
LBN
Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
LBP
Replacement, Ossicular (Stapes) Using Absorbable Gelatin Material
LDG
Kit, Earmold, Impression
LRB
Face Plate Hearing Aid
LRE
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile
LWF
Dilator, Nasal
LXB
Hearing Aid, Bone Conduction
K
21
3733
Ponto 5 SuperPower
K
21
2136
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
K
21
1640
Ponto 5 Mini
K
20
2048
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
K
19
0540
Ponto 4
K
17
2460
ADHEAR System
K
17
1088
Cochlear Baha SoundArc
K
16
1671
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
K
15
3391
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
K
16
1123
Baha 5 Power Sound Processor
K
15
3245
Baha 5 Super Power Sound Processor
K
15
0751
Cordelle II Sound Processor
K
14
2907
Baha 5 Sound Processor
K
13
2775
PONTO PLUS AND PONTO PLUS POWER
K
13
2189
OTOMAG BONE CONDUCATION HEARING SYSTEM
K
13
1240
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
K
13
2278
COCHLEAR BAHA 4 SOUND PROCESSOR
K
12
3962
OTOMAG BONE CONDUCTION HEARING SYSTEM
K
12
1793
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
K
11
0831
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
K
10
3594
PONTO PRO POWER
K
10
2199
OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
K
11
0996
BAHA 3 POWER SOUND PROCESSOR
K
10
0649
SOUNDBITE HEARING SYSTEM BY SONITUS
K
10
0360
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
K
10
0193
OTOMAG BONE CONDUCTION HEARING SYSTEM
K
09
0996
PONTO PRO
K
09
0720
COCHLEAR BAHA BP100
K
08
2108
OBC BONE ANCHORED HEARING AID SYSTEM
K
08
1606
BAHA INTENSO
K
06
2404
TRANSEAR BONE CONDUCTION HEARING AID
K
05
0653
TRANSEAR BONE CONDUCTION HEARING AID
K
04
2017
BAHA DIVINO
K
02
1837
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
K
01
1438
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
K
00
2913
HEADBAND FOR BAHA
K
99
2872
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
K
95
5713
NOBELPHARMA BONE ANCHORED HEARING AID
K
95
3872
SECOND EAR BONE CONDUCTION HEARING AID
K
95
1678
HI SONIC 2000 DIGITAL HEARING INSTRUMENT
K
93
5701
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
K
88
4056
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
K
88
1382
XOMED AUDIANT BONE CONDUCTOR
K
87
5277
ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
K
87
2168
XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.
K
86
1971
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
K
85
5059
AUDIANT BONE CONDUCTOR OR A.B.C.
LZI
Device, Assistive Listening
MAH
Hearing Aid, Bone Conduction, Implanted
MCK
Device, Voice Amplification
MIX
System, Vocal Cord Medialization
NHB
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
NIX
Hearing Aid, Air Conduction, Transcutaneous System
NNN
Crimper, Wire, Ent, Non-Sterile
NNO
Jig, Piston Cutting, Ent, Non-Sterile
NNP
Die, Wire Bending, Ent, Non-Sterile
NNQ
Forceps, Wire Closure, Ent, Non-Sterile
NNR
Block, Cutting, Ent, Non-Sterile
NNS
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile
NNT
Punch, Gelfoam, Non-Sterile
NNU
Scissors, Wire Cutting, Ent, Non-Sterile
NNV
Vise, Ossicular Finger, Non-Sterile
OGS
Myringotomy Procedure Kit
OSM
Hearing Aid, Air Conduction With Wireless Technology
PFO
Active Implantable Bone Conduction Hearing System
PLK
Tympanic Membrane Direct Contact Hearing Aid
QDD
Self-Fitting Air-Conduction Hearing Aid
QUF
Hearing Aid, Air-Conduction, Over The Counter
QUG
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
QUH
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
EN
/
subpart-d—prosthetic-devices
/
LXB
/
K011438
View Source
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K011438
510(k) Type
Traditional
Applicant
ENTIFIC MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/23/2001
Days to Decision
74 days
Submission Type
Summary