Beltone Personal Hearing Screener

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

510(k) Number

K943616 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Beltone Comparafit

  Class I

  FDA 510(k) K946340 Active Cleared 13 Apr 1995

• Otosonic Cf-2, Cf-2 Ic, Cf-2 Anf, Cf-2 with Improved Class D (Delta Amp)

  Class I

  FDA 510(k) K940177 Active Cleared 1 Apr 1994

• Beltone Optima 2000 Clearvoice Series, in-the-Ear

  Class I

  FDA 510(k) K930310 Active Cleared 1 Mar 1993

• The Beltone Audio Scout

  Class II

  FDA 510(k) K915323 Active Cleared 11 May 1992

• Beltone Invisa

  Class I

  FDA 510(k) K940098 Active Cleared 15 Jun 1994

• Otosonic Acs-Ic

  Class I

  FDA 510(k) K922224 Active Cleared 27 May 1992

See all devices from Beltone Electronics Corp. →

• What is the Beltone Personal Hearing Screener used for?

  The Beltone Personal Hearing Screener is an audiometer designed to evaluate hearing acuity by presenting pure-tone signals. It measures an individual’s ability to detect and discriminate sounds across different frequencies, making it ideal for clinical or screening assessments in ear, nose, and throat specialties. This helps clinicians identify hearing thresholds for diagnostic purposes.

• How is the Beltone Personal Hearing Screener supplied and can it be reused?

  The Beltone Personal Hearing Screener is supplied as a portable, non-sterile instrument. Whether it can be reused depends on facility protocols, as it is intended for both single-use and reusable applications. Facilities must establish their own cleaning and disinfection procedures to ensure proper reuse in compliance with standard audiometric equipment guidelines.

• Is the Beltone Personal Hearing Screener sterile?

  No, the Beltone Personal Hearing Screener is explicitly described as a non-sterile device. Sterility is not required for its intended use in clinical hearing assessments, as it is designed for direct interaction with patients but not for invasive procedures.

• What regulatory approval does the Beltone Personal Hearing Screener hold?

  The Beltone Personal Hearing Screener holds FDA 510(k) clearance under the classification of EWO (Ear, Nose, and Throat) with the clearance number K943616. This approval confirms it is substantially equivalent to a legally marketed device and is intended for diagnostic hearing assessments in accredited healthcare settings.

• What storage and handling guidelines apply to the Beltone Personal Hearing Screener?

  The Beltone Personal Hearing Screener follows standard audiometric equipment guidelines for storage and handling. Since it is non-sterile and portable, it should be stored in a clean, dry environment to prevent contamination or damage. Reusable units must undergo proper cleaning and disinfection before each use, adhering to facility protocols to maintain functionality and hygiene.