Odyssey Clinical Audiometer

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

510(k) Number

K935348 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• At-2

  Class II

  FDA 510(k) K923007 Active Cleared 26 Feb 1993

• Elegance

  Class I

  FDA 510(k) K812578 Active Cleared 2 Oct 1981

• Acoustic Appraiser CD-2 Audiometer/Master Hear.Aid

  Class II

  FDA 510(k) K904544 Active Cleared 31 Oct 1990

• As-90

  Class I

  FDA 510(k) K923006 Active Cleared 18 Sep 1993

• Compression Multisonic

  Class I

  FDA 510(k) K780241 Active Cleared 17 Feb 1978

• Qualitone Model 48 C-Wr-Behind the Ear

  Class I

  FDA 510(k) K912154 Active Cleared 17 Jun 1991

See all devices from Qualitone →

• What clinical settings is the Odyssey Clinical Audiometer intended for use in, and how does it help in diagnosing hearing issues?

  The Odyssey Clinical Audiometer is designed for audiology clinics, otolaryngology offices, and hearing healthcare facilities. It measures hearing sensitivity and assesses auditory function by generating pure-tone signals and speech stimuli across various frequencies. This helps clinicians evaluate hearing thresholds, aiding in the diagnosis and ongoing monitoring of hearing disorders.

• Is the Odyssey Clinical Audiometer a single-use or reusable device, and what does this mean for maintenance and cleaning?

  The Odyssey Clinical Audiometer is a reusable clinical instrument. Since it is not single-use, proper cleaning and maintenance protocols must be followed to ensure hygiene and functionality between patient use. The manufacturer’s guidelines should be consulted for specific cleaning instructions.

• What regulatory pathway was followed for FDA clearance of the Odyssey Clinical Audiometer, and what does this classification mean for its use?

  The Odyssey Clinical Audiometer received FDA clearance through a 510(k) pathway (K935348) under the Traditional clearance type, determined to be substantially equivalent to a predicate device. It is classified as a Class II medical device under 21 CFR 874.1050, meaning it is subject to general controls and special controls specific to audiometers, ensuring its safety and effectiveness for measuring hearing sensitivity in clinical settings.

• Are there multiple models or configurations of the Odyssey Clinical Audiometer, and how can I identify the correct version for my facility?

  The provided data lists multiple FEI numbers (e.g., 3013557562, 3008717264) associated with the Odyssey Clinical Audiometer, which may correspond to different models or variants. These identifiers are used in regulatory filings and could indicate variations in specifications or software versions. For precise model selection, consult Qualitone’s documentation or contact their support team, as these FEI numbers do not directly translate to user-facing model names.