FDA.reportPublic FDA data

Tone audiometer, automated

Definition
An electroacoustic device designed to be used in a clinical setting to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. A computer or microprocessor in the device automatically produces tones that sweep the audiometric scale and controls tone intensity and frequency. The device also records the patient's responses and may display calculated hearing thresholds. This device may have the capacity to present a fixed frequency or a steadily changing frequency. It may also provide both continuous and pulsed tone outputs.
GUDID devices
35
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M737G50001OtogramOtotronix, LLCG50002016-09-13
M737G55001OtogramOtotronix, LLCG55002016-09-13
M737ML40001OtogramOtotronix, LLCML40002016-09-13
M737S3000R1OtogramOtotronix, LLCS3000R2016-09-13
M737S50001OtogramOtotronix, LLCS50002016-09-13
M737S55001OtogramOtotronix, LLCS55002016-09-13
05713315005893NatusNatus Medical Denmark ApS8-75-4352021-09-13
05713557000038OscillaInmedico A/SSM920-P2016-09-21
05713557000090OscillaInmedico A/SUSB3102016-09-21
00732094300581Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-03-19
00732094300598Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-03-19
00732094300604Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-03-19
00732094300611Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-03-19
00732094300628Welch Allyn, Inc.WELCH ALLYN, INC.9010012020-03-19
57135570000032OscillaInmedico A/SSM920-P2016-09-21
57135570000094OscillaInmedico A/SUSB3102016-09-21
57135570000003OscillaInmedico A/SSM920-P2016-09-21
57135570000009OscillaInmedico A/SUSB3102016-09-21
B2075002960NABENSON MEDICAL INSTRUMENTS COMPANYNEXT2016-09-16
B2075003030NABENSON MEDICAL INSTRUMENTS COMPANYCCA-200M2016-09-16
B2075003070NABENSON MEDICAL INSTRUMENTS COMPANYCCA-100M2016-09-16
B2075003220NABENSON MEDICAL INSTRUMENTS COMPANYSMART TONE2016-09-16
B2075004420Benson Medical Instruments Co.BENSON MEDICAL INSTRUMENTS COMPANYCCF2002017-05-01
05713315005954OtometricsNatus Medical Denmark ApSMadsen A4502017-06-07
05713315005961OtometricsNatus Medical Denmark ApSMadsen A4502017-06-07
05713315005978OtometricsNatus Medical Denmark ApSMadsen A4502017-06-07
00851195007035AMBCOAMBCO ELECTRONICS1000+P2016-10-12
00851195007042AMBCOAMBCO ELECTRONICS25002016-10-12
00862185000325Earscan 3MICRO AUDIOMETRICS CORPORATIONES32016-09-08
00732094083460Welch Allyn, Inc.WELCH ALLYN, INC.9010022016-09-17
00732094083477Welch Allyn, Inc.WELCH ALLYN, INC.9010022016-09-17
00732094083484Welch Allyn, Inc.WELCH ALLYN, INC.9010022016-09-17
00732094083491Welch Allyn, Inc.WELCH ALLYN, INC.9010022016-09-17
00732094083705Welch Allyn, Inc.WELCH ALLYN, INC.9010022016-09-17
00732094140507Welch Allyn, Inc.WELCH ALLYN, INC.9010022016-09-17