Acoustic Impedance Meter, Model TA-4D

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

510(k) Number

K801293 ↗

FDA Product Code

ETY

Device Class

Class II

Regulation

21 CFR Part 874.1090

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Ta-10 Portable Screening Audiometer

  Class II

  FDA 510(k) K791467 Active Cleared 28 Sep 1979

• Clinical Audiometer Model Ta-200

  Class II

  FDA 510(k) K801325 Active Cleared 30 Jun 1980

• Ta-201 Clinical Audiometer

  Class II

  FDA 510(k) K844069 Active Cleared 3 Dec 1984

• Spirometer Model Ts-200 Slz 7541

  Class II

  FDA 510(k) K855070 Active Cleared 30 Jan 1986

• Automatic Impedance Audiometer, Ta-7B

  Class II

  FDA 510(k) K854043 Active Cleared 31 Dec 1985

• Spirometer, Model Ts-500 Part #SLZ7534

  Class II

  FDA 510(k) K855068 Active Cleared 5 Feb 1986

See all devices from Teledyne Avionics Div. of Teledyne →

• What clinical conditions can the Acoustic Impedance Meter, Model TA-4D, help diagnose or assess in patients?

  The TA-4D measures acoustic impedance in the ear canal to evaluate middle ear function, tympanic membrane mobility, and acoustic reflex thresholds. This objective data helps diagnose conditions like otitis media, Eustachian tube dysfunction, or hearing impairments, particularly in clinical Ear, Nose, and Throat settings.

• Is the Acoustic Impedance Meter, Model TA-4D, intended for single-use or reusable applications, and does it require sterilization?

  The TA-4D is designed as a reusable instrument and does not require sterilization between uses, as specified in its regulatory documentation. This makes it suitable for repeated clinical assessments without additional processing.

• What regulatory pathway was followed for the FDA clearance of the Acoustic Impedance Meter, Model TA-4D?

  The TA-4D received FDA clearance through a 510(k) submission (K801293) under the traditional review pathway, classified as a Class II device under regulation 874.1090. The submission was reviewed by the Ear, Nose, and Throat (EN) Advisory Committee in 1980.

• Which medical specialties would primarily benefit from using the Acoustic Impedance Meter, Model TA-4D?

  The TA-4D is explicitly intended for use in Ear, Nose, and Throat (ENT) clinical settings, where professionals assess middle ear health, tympanic membrane integrity, and hearing-related conditions. Its design aligns with diagnostic needs in this specialty.