FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Baha 5 Super Power Sound Processor
K Number: K153245
·
Decision Mar 2, 2016
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
50
Applicant Total
20
Review Days
114
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Basic Information
- Device Name
- Baha 5 Super Power Sound Processor
- K Number
- K153245
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3302
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cochlear Americas
- Date Received
- November 9, 2015
- Decision Date
- March 2, 2016
- Product Code
- LXB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LXB | Hearing Aid, Bone Conduction | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LXB), ordered by most recent decision date.
Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
contact forte Alpha
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Ponto 5 SuperPower
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Cochlear Americas
| K Number | Device Name | ||
|---|---|---|---|
| K240155 | Cochlear Osia System | Apr 18, 2024 | Substantially Equivalent |
| K231604 | Instrument Case | Aug 24, 2023 | Substantially Equivalent |
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit | Jul 27, 2022 | Substantially Equivalent |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | Sep 29, 2021 | Substantially Equivalent |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | Feb 23, 2021 | Substantially Equivalent |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments | Nov 15, 2019 | Substantially Equivalent |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments | Jul 3, 2019 | Substantially Equivalent |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | Dec 19, 2018 | Substantially Equivalent |
| K171088 | Cochlear Baha SoundArc | Jun 7, 2017 | Substantially Equivalent |
| K161123 | Baha 5 Power Sound Processor | May 20, 2016 | Substantially Equivalent |