Acoustic Appraiser CD-2 Audiometer/Master Hear.Aid

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

510(k) Number

K904544 ↗

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

• 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

• Super X Adjustrette

  Class II

  FDA 510(k) K770251 Active Cleared 28 Feb 1977

See all devices from Qualitone →

• What is the Acoustic Appraiser CD-2 Audiometer/Master Hear.Aid used for?

  It is a clinical console designed for audiometric testing to measure hearing sensitivity and for hearing aid simulation, intended for use in Ear, Nose, Throat specialty applications.

• Is the Acoustic Appraiser CD-2 Audiometer/Master Hear.Aid reusable or single-use?

  It is supplied as a reusable device, meaning it can be used multiple times after appropriate cleaning and maintenance, as indicated in its description.

• How is the Acoustic Appraiser CD-2 Audiometer/Master Hear.Aid supplied?

  The device is supplied in an integrated carrying case, which provides protection and portability for the reusable clinical console.

• What regulatory pathway was used for the Acoustic Appraiser CD-2 Audiometer/Master Hear.Aid?

  The device received FDA 510(k) clearance under number K904544, indicating it was found substantially equivalent to a legally marketed predicate device.

• What is the classification and regulation number for the Acoustic Appraiser CD-2 Audiometer/Master Hear.Aid?

  It is classified as a Class II medical device under regulation number 874.1050, which governs audiometers for Ear, Nose, Throat specialty applications.