Microscreen I Hearing Tester
by Microscreen
510(k) K863979
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863979 | Date18 Nov 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EWO
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.1050
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Microscreen I Hearing Tester is an audiometer, a diagnostic device designed to measure hearing acuity by presenting pure-tone signals to assess an individual’s ability to detect and interpret sound across different frequencies and intensities. It evaluates auditory function in clinical settings, supporting the diagnosis and management of hearing impairments, including conductive or sensorineural hearing loss, tinnitus, or other ear-related conditions.
This device is intended for use in clinical environments by audiologists, otolaryngologists, or hearing healthcare professionals. Supplied as a reusable medical instrument, it operates under regulatory oversight as a Class II device under FDA 510(k) clearance (K863979) and falls under regulation 874.1050. No specific sterility or MRI safety information is provided in the data, and its design does not include interchangeable or disposable components. Storage and maintenance instructions are not detailed in the specifications.
Questions
AI-generated answers, 1 Oct 2026
What is the Microscreen I Hearing Tester used for?
The Microscreen I Hearing Tester is an audiometer designed to measure hearing acuity by presenting pure-tone signals. It evaluates an individual’s ability to detect and interpret sound across different frequencies and intensities, helping clinicians diagnose and manage hearing impairments such as conductive or sensorineural hearing loss, tinnitus, or other ear-related conditions. It is specifically intended for use in clinical environments by audiologists, otolaryngologists, or hearing healthcare professionals.
How is the Microscreen I Hearing Tester supplied and maintained?
The Microscreen I Hearing Tester is supplied as a reusable medical instrument. Since it is not described as having disposable or interchangeable components, proper cleaning and maintenance protocols must be followed to ensure its reliability and longevity. However, specific storage and maintenance instructions are not detailed in the provided specifications, so users should refer to the manufacturer’s guidelines for optimal care.
Is the Microscreen I Hearing Tester sterile?
The provided data does not specify whether the Microscreen I Hearing Tester is sterile or requires sterilization. As a reusable device, it should be cleaned and disinfected according to clinical standards to prevent cross-contamination between patients. Always follow infection control protocols specific to your facility.
What regulatory approval does the Microscreen I Hearing Tester have?
The Microscreen I Hearing Tester holds FDA 510(k) clearance under the reference number K863979, classified as a Class II device under regulation 874.1050. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and meets FDA requirements for safety and effectiveness in its intended use.
Are there different models or sizes available for the Microscreen I Hearing Tester?
The provided data does not specify multiple models or sizes for the Microscreen I Hearing Tester. It is listed as a singular device under the name 'MICROSCREEN I HEARING TESTER,' with no mention of variations. For any additional configurations or customization options, users should consult the manufacturer directly.