Interacoustics Clinical Impedance Audiometer AZ26

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K942007 ↗

FDA Product Code

ETY

Device Class

Class II

Regulation

21 CFR Part 874.1090

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Interacoustics Clinical Audiometer

  Class II

  FDA 510(k) K941920 Active Cleared 16 Sep 1994

• Interacoustics Computer Audiometer Ba 20

  Class II

  FDA 510(k) K943066 Active Cleared 24 Aug 1994

• Interacoustics. Hearing Aid Analyzer

  Class II

  FDA 510(k) K941848 Active Cleared 23 May 1994

• Interacoustics Automatic Impedance Audiometer

  Class II

  FDA 510(k) K942008 Active Cleared 24 Aug 1994

• Interacoustics Hearing Aid Analyzer Ms 40

  Class II

  FDA 510(k) K943607 Active Cleared 23 Sep 1994

• Interacoustics Diagnostic Audiometer

  Class II

  FDA 510(k) K942006 Active Cleared 20 Jun 1994

See all devices from Precision Acoustics Ind., Inc. →

• What clinical conditions does the AZ26 help diagnose using tympanometry and acoustic reflex testing?

  The AZ26 Clinical Impedance Audiometer AZ26 is designed to assess middle ear function and diagnose otologic disorders through tympanometry and acoustic reflex testing. Tympanometry evaluates middle ear pressure and mobility, while acoustic reflex testing measures the contraction of middle ear muscles in response to loud sounds. These tests help identify conditions such as fluid in the middle ear, perforated eardrums, or issues with the ossicles, ensuring accurate diagnosis for patients with hearing or balance concerns.

• Is the AZ26 a single-use or reusable device, and what are the maintenance requirements?

  The AZ26 is a reusable, non-sterile instrument intended for professional use in clinical settings. To maintain accuracy and performance, it must be cleaned and calibrated according to the manufacturer’s guidelines after each use. Proper storage and regular maintenance are critical to ensure reliable test results over its operational lifespan, as outlined in the device’s user manual.

• What types of environments is the AZ26 intended for, and does it have any compatibility restrictions?

  The AZ26 is supplied for clinical use in Ear, Nose, and Throat (ENT) settings, where audiologists or hearing specialists perform diagnostic evaluations. It is not MRI-compatible, meaning it should not be used or stored near MRI machines, as electromagnetic interference could affect its performance or safety.

• What regulatory approvals does the AZ26 hold, and who is authorized to operate it?

  The AZ26 holds FDA clearance under 510(k) number K942007, classified as a Class II medical device. It is intended for use by trained audiologists or hearing specialists, as these professionals are qualified to interpret test results and diagnose hearing-related conditions based on the device’s measurements.

• What specific tests does the AZ26 perform, and how do they contribute to patient assessment?

  The AZ26 performs tympanometry (measuring middle ear pressure and mobility), acoustic reflex testing (evaluating muscle responses to sound), and air conduction audiometry (assessing hearing sensitivity across frequencies). These tests collectively help clinicians assess middle ear function, identify conductive hearing loss, and diagnose conditions like otitis media or Eustachian tube dysfunction, ensuring comprehensive patient evaluation.