K 15 Audiometer

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

510(k) Number

K972221 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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See all devices from American Electromedics Corp. →

• What clinical environments is the K-15 Audiometer intended for, and how is it typically used there?

  The K-15 Audiometer is designed for clinical settings like audiology clinics or ENT (ear, nose, and throat) departments. It measures hearing sensitivity by assessing pure-tone thresholds across different frequencies, providing objective data to evaluate auditory function. This helps in diagnosing and monitoring hearing loss or other auditory disorders, and it is administered by trained professionals during hearing tests.

• Is the K-15 Audiometer a single-use or reusable device, and what maintenance does it require?

  The K-15 Audiometer is a reusable medical instrument. To ensure accuracy and reliability, it requires proper calibration and regular maintenance as part of its operational protocol. This is critical for maintaining the device’s performance over time.

• How was the K-15 Audiometer regulated by the FDA, and what does this mean for its use?

  The K-15 Audiometer was cleared by the FDA through a 510(k) pathway, specifically under clearance number K972221, and is classified as a Class II device under 21 CFR 874.1050. This means it has been determined to be substantially equivalent to a legally marketed device and meets FDA safety and effectiveness requirements for audiometers. The clearance reflects its intended use in clinical settings for measuring hearing sensitivity.

• What is the regulatory route for the K-15 Audiometer, and how does it relate to its classification?

  The K-15 Audiometer was reviewed by the FDA’s Ear, Nose, and Throat (EN) Advisory Committee and cleared through a traditional 510(k) process. It is classified as a Class II device, which means it is subject to special controls to ensure its safety and effectiveness, including performance standards and post-market surveillance requirements. This classification aligns with its use in diagnosing and monitoring auditory function.