Audiometer, Portable, Air Conduction

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

510(k) Number

K780382 ↗

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. →

• What clinical settings is this portable audiometer designed for and how does it differ from traditional audiometers?

  The MA 25 Portable Audiometer is specifically designed for air conduction hearing assessments in clinical, school, or field settings, making it ideal for environments where mobility and flexibility are important. Unlike traditional audiometers, this model is portable, allowing for use outside of fixed examination rooms. It measures hearing thresholds across a frequency range of 125 Hz to 8000 Hz and a decibel range of -10 to 100 dBHL, with adjustable steps of 1 or 5 dB, ensuring precise evaluation of auditory function for detecting hearing impairments.

• Is this device reusable or single-use, and what does that mean for maintenance and cleaning?

  The MA 25 Portable Audiometer is reusable and non-sterile, meaning it is intended for repeated use across multiple patients. Since it is not sterile, proper cleaning and maintenance are required between uses to ensure hygiene and accuracy. The manufacturer’s instructions (not provided here) should outline recommended cleaning protocols to prevent contamination and preserve the device’s functionality.

• How does the regulatory pathway for this device impact its use in healthcare settings?

  This device was granted FDA 510(k) clearance (K780382) under the Traditional 510(k) review pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance allows it to be legally marketed and used in U.S. healthcare settings for its intended purpose—air conduction hearing assessment—while adhering to regulatory standards outlined in 21 CFR 874.1050. The classification under product code EWO further confirms its designation as a Class II medical device.

• What frequency and decibel ranges does this audiometer cover, and how does that affect its diagnostic capabilities?

  The MA 25 Portable Audiometer covers a frequency range of 125 Hz to 8000 Hz and a decibel range of -10 to 100 dBHL, with adjustable steps of 1 or 5 dB. This broad range allows for comprehensive evaluation of hearing thresholds across low to high frequencies, enabling accurate detection of hearing impairments, including mild to severe hearing loss. The adjustable dB steps enhance precision in threshold determination, which is critical for clinical assessments.