Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-167: ANSI S3.21, Methods for Manual Pure-Tone Threshold Audiometry. (Dental/ENT)
Date of Standard: 2009. |
| Address of Standards Organization: |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
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| Devices Affected: |
| Hearing Aids, Implantable Middle-Ear Hearing Devices, Cochlear Implants, Auditory Brainstem Implants, Diagnostic Test Equipment, Tinnitus Maskers |
|
| Processes Affected: |
| 510(k), IDE, PMA, PDP, HDE, Quality System Regulation |
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| Type of Standard: |
| Horizontal, National |
| Extent of Recognition: |
| Complete standard and any annexes. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Implant, Cochlear |
Class 3 |
MCM |
| Unclassified |
Implant, Hearing, Active, Middle Ear, Partially Implanted |
Class 3 |
MPV |
| §874.3950 |
Hearing Aid, Air Conduction, Transcutaneous System |
Class 2 |
NIX |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.1050 |
Audiometer |
Class 2 |
EWO |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.1080 |
Set, Audiometer Calibration |
Class 1 |
EWA |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.3300 |
Hearing Aid, Air Conduction |
Class 1 |
ESD |
| §874.3300 |
Hearing Aid, Bone Conduction |
Class 2 |
LXB |
| §874.3300 |
Hearing Aid, Bone Conduction, Implanted |
Class 2 |
MAH |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.3400 |
Masker, Tinnitus |
Class 2 |
KLW |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.3950 |
Hearing Aid, Air Conduction, Transcutaneous System |
Class 2 |
NIX |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| James K. Kane, Ph.D. |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2432 |
| Silver Spring MD 20993 |
| 301/796-6477 |
| Email: james.kane@fda.hhs.gov |
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