Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-177: ANSI / ASA S12.65-2006 (Revision of ANSI S3.14-1977), American National Standard For Rating Noise with Respect to Speech Interference. (Dental/ENT)
Date of Standard: 2006. |
| Addresses of Standards Organizations: |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
| Acoustical Society of America (ASA) |
| 500 Sunnyside Boulevard |
| Woodbury, NY 11797-2999 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
|
|
| Devices Affected: |
| Hearing Aids, Implantable Middle-Ear Hearing Devices, Cochlear Implants, Auditory Brainstem Implants |
|
| Processes Affected: |
| 510(k), IDE, PMA, PDP, HDE, Quality System Regulation |
|
| 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 |
| §874.3300 |
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 |
| §874.3950 |
Hearing Aid, Air Conduction, Transcutaneous System |
Class 2 |
NIX |
| |
|
| Relevant Guidance: |
| Guidance for Industry - Noise Claims in Hearing Air Labeling Document issued on: October 21, 1998 |
|
| FDA Technical Contact: |
| Shu-Chen Peng |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66 Room 2446 |
| Silver Spring MD 20993 |
| 301/796-6481 |
| Email: shu-chen.peng@fda.hhs.gov |
|
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