KS 5 Clinical Audiometer

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

510(k) Number

K931322 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Faceplate, Custom in-the-Ear Hearing Aid, Fpr

  Class I

  FDA 510(k) K862769 Active Cleared 13 Aug 1986

• Hearing Aid, Series R

  Class I

  FDA 510(k) K770960 Active Cleared 14 Jun 1977

• Series M Push-Pull Input Compression

  Class I

  FDA 510(k) K821760 Active Cleared 25 Jun 1982

• Model P20/P21 in-the-Ear Hearing Aid

  Class I

  FDA 510(k) K882692 Active Cleared 15 Jul 1988

• Maico MA800 Audiometer

  Class II

  FDA 510(k) K911368 Active Cleared 26 Jun 1991

• Ma 610-Impedance Audiometer

  Class II

  FDA 510(k) K831754 Active Cleared 7 Jul 1983

See all devices from Maico Hearing Instruments, Inc. →

• Is the KS 5 Clinical Audiometer designed for single-use or can it be reused in clinical settings?

  The KS 5 Clinical Audiometer is explicitly described as a reusable instrument for clinical use in audiology clinics and ENT practices. Since no sterility requirements or cleaning instructions are mentioned in the provided data, users should follow standard infection control protocols for reusable medical devices to ensure safe, repeated use.

• What types of hearing assessments can the KS 5 Clinical Audiometer perform?

  The KS 5 Clinical Audiometer generates pure-tone signals and speech stimuli to evaluate hearing thresholds across different frequencies. This allows clinicians to diagnose and monitor hearing impairments by measuring auditory function in a clinical setting.

• How is the regulatory status of this device determined, and what does that mean for purchasing?

  The KS 5 Clinical Audiometer holds FDA 510(k) clearance (K931322) under the classification 21 CFR 874.1050, with a decision of *Substantially Equivalent* to a predicate device. This means it has been reviewed by the FDA and deemed comparable to existing audiometers in terms of safety and effectiveness, ensuring it meets regulatory standards for clinical use in the U.S.

• Are there different models or sizes available for the KS 5 Clinical Audiometer?

  The provided data does not specify variations in sizes or distinct models for the KS 5 Clinical Audiometer. However, the OpenFDA registration numbers suggest multiple listings, which may indicate different configurations or accessories (e.g., calibration tools or software versions) rather than physical size variations. For exact specifications, consult the manufacturer’s documentation.