FDA.reportPublic FDA data

Hearing aid tester, electrical

Definition
An assembly of electronic reference devices intended to be used by a healthcare provider in a clinical setting to verify the performance of and/or calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid or group auditory trainer. The device typically consists of an acoustic complex of known cavity volume, a sound level meter, microphone, oscillators, frequency counters, microphone amplifiers, distortion analyser, chart recorder, and a hearing aid test box; some types may include a probe microphone used for real-ear measurement (REM). It does not measure hearing acuity [i.e., it is not an audiometer].
GUDID devices
20
Last updated
2026-06-17 06:05:17

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05713315000874GN Otometrics A/SNatus Medical Denmark ApSOTOair Bluetooth Dongle2016-09-19
05713315001055GN Otometrics A/SNatus Medical Denmark ApSFreeFit REM probe2016-09-19
05713315001192GN Otometrics A/SNatus Medical Denmark ApSPMM RECD Probe Short2016-09-19
05713315001208GN Otometrics A/SNatus Medical Denmark ApSPMM RECD Probe Long2016-09-19
05713315001215GN Otometrics A/SNatus Medical Denmark ApSPMM RECD Probe Bin Long2016-09-19
05713315001222GN Otometrics A/SNatus Medical Denmark ApSPMM RECD Probe Bin Short2016-09-19
05713315001246GN Otometrics A/SNatus Medical Denmark ApSRECD Eartip Kit2016-09-19
05713315001253GN Otometrics A/SNatus Medical Denmark ApSRECD Fitting Kit2016-09-19
05713315001277GN Otometrics A/SNatus Medical Denmark ApSSoundHub 1002016-09-26
05713315003301GN Otometrics A/SNatus Medical Denmark ApSREM Test tubes, 1.1mm (50 pcs.)2018-07-31
05713315004100GN Otometrics A/SNatus Medical Denmark ApSAurical FreeFit, Complete Solution2016-09-19
05713315004117GN Otometrics A/SNatus Medical Denmark ApSAurical FreeFit, Complete Solution2016-09-19
05713315005701GN Otometrics A/SNatus Medical Denmark ApSREM Tube with ruler2018-11-06
05713315005848GN Otometrics A/SNatus Medical Denmark ApSProbe Tube Holder mk22019-04-24
05713315008184GN Otometrics A/SNatus Medical Denmark ApSOTOair 2 Bluetooth Dongle2019-03-18
05713315008689NatusNatus Medical Denmark ApS1053 Freefit Charger2021-01-04
05713315009051NatusNatus Medical Denmark ApS8-62-453002021-04-12
05711781004297Measure by Otometrics - HITAuditdata A/SHIT Pro Package2025-11-14
05711781004372Measure by Otometrics - HITAuditdata A/SUS/CA AUD HIT Pro Package2025-11-14
05711781004006Unity 3Auditdata A/SUnity 3 HIT UNIT US package 2024-10-21