Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-160: ANSI S3.1, Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms. (Dental/ENT)
Date of Standard: 2008. |
| Address of Standards Organization: |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
|
| 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, Electric-Acoustic Devices, Diagnostic Test Equipment, Diagnostic Test Equipment Calibrators, Tinnitus Maskers |
|
| 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 |
| §874.1050 |
Audiometer |
Class 2 |
EWO |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.1060 |
Chamber, Acoustic (For Audiometric Testing) |
Class 1 |
EWC |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.1080 |
Set, Audiometer Calibration |
Class 1 |
EWA |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.1090 |
Tester, Auditory Impedance |
Class 2 |
ETY |
| §874.1090 |
Tympanometer |
Class 2 |
NAS |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.3300 |
Hearing Aid, Air Conduction |
Class 1 |
ESD |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §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: |
Class II Special Controls Guidance Document: Transcutaneous Air Circulation Hearing Aid System (TACHAS); Guidance for Industry and FDA. Document issued on November 7, 2002
Guidance for Industry and FDA Staff Implantable Middle Ear Hearing Device Document issued on: August 1, 2003
Draft Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Tinnitus Masker Devices. Document issued on November 8, 2005
Guidance for Industry - Noise Claims in Hearing Aid 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 |
|
|
|
|
