Audiometer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790609 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Middle Ear Analyzer (Impedance Audiometer)

  Class II

  FDA 510(k) K863353 Active Cleared 3 Nov 1986

• Middle Ear Analyzer (Impedance Audio

  Class II

  FDA 510(k) K820715 Active Cleared 9 Apr 1982

• Middle Ear Analyzer (Imped. Audiomtr)

  Class II

  FDA 510(k) K790846 Active Cleared 17 May 1979

• GSI Novus

  Class II

  FDA 510(k) K172403 Active Cleared 20 Oct 2017

• The Screener Gsi 55 Abr Screener

  Class II

  FDA 510(k) K870030 Active Cleared 13 Mar 1987

• GSI Audera Pro

  Class II

  FDA 510(k) K193033 Active Cleared 24 Apr 2020

See all devices from Grason-Stadler, Inc. →

• What clinical settings is this audiometer intended for use in and how does it assess hearing function?

  This audiometer is designed for use in audiology clinics, hospitals, and research facilities to measure hearing acuity. It evaluates auditory function by presenting pure-tone signals and speech stimuli across various frequencies, allowing clinicians to determine hearing thresholds and identify potential hearing loss or impairment.

• Is this audiometer reusable or single-use, and what are the sterility considerations?

  The audiometer is supplied as a reusable, non-sterile instrument. Since it is not intended for sterile procedures, it does not require sterilization between uses, but proper cleaning and maintenance are necessary to ensure accurate and reliable performance.

• How is the regulatory status of this audiometer determined, and what classification does it fall under?

  This audiometer is regulated under the FDA’s 510K clearance process, specifically with the clearance number K790609, and is classified as a Class II medical device under regulation number 874.1050. It was determined to be substantially equivalent to a predicate device through a traditional review by the Ear, Nose, and Throat (ENT) advisory committee.

• Are there multiple models of this audiometer, and how do they differ?

  Yes, multiple models of this audiometer exist, as indicated by the listed FEI numbers (e.g., 1000307595, 3002816805). While specifications may vary between models, all adhere to standardized testing protocols for accurate hearing assessment, ensuring consistency in clinical use.