Pilot Test or Detective Audiometers
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060883 FDA 510(k)
- FDA Product Code
- EWO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.1050 FDA 510(k)
- Regulation Number
- 874.1050 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Pilot Test or Detective Audiometers are manual single channel pure tone air conduction audiometers used to test the hearing thresholds of children. The Pilot Test audiometer has the additional capability of using speech testing using "select picture" audiometry with Spondee word lists.
These devices are supplied by Interacoustics A/S and were cleared through the FDA 510(k) process under K060883 with product code EWO. They are classified as Class II devices for Ear, Nose, Throat applications and received clearance on June 23, 2006.
Frequently asked questions
What is the Pilot Test or Detective Audiometer used for?
It is a manual single channel pure tone air conduction audiometer designed to test the hearing thresholds of children, with the Pilot Test version additionally capable of speech testing using 'select picture' audiometry and Spondee word lists.
How is the Pilot Test or Detective Audiometer supplied?
The device is supplied by Interacoustics A/S as a manual audiometer system intended for clinical use in pediatric hearing assessment, based on its FDA 510(k) clearance documentation.
Is the Pilot Test or Detective Audiometer a single-use or reusable device?
As a manual audiometer used for air conduction testing, it is a reusable clinical instrument; the device description does not indicate any single-use components or disposables, consistent with standard audiometer design.
What model or reference distinguishes the Pilot Test or Detective Audiometer from similar devices?
The device is identified by the name 'PILOT TEST OR DETECTIVE AUDIOMETERS' and was cleared under FDA 510(k) number K060883 with product code EWO, which distinguishes it from other audiometers in the manufacturer's lineup.
What are the storage and handling considerations for the Pilot Test or Detective Audiometer?
While specific storage conditions are not detailed in the provided data, as a clinical electronic device cleared under FDA 510(k), it should be stored in a clean, dry environment according to standard medical equipment guidelines to maintain calibration and functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PILOT TEST OR DETECTIVE AUDIOMETERS by INTERACOUSTICS A/S | FDA 510(k ..., fda.innolitics.com, PDF K060883 - Pilot Test or Detective Audiometers, Equipment for Diagnostic Audiology and Balance Testing | Interacoustics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060883 | Class II | Active |
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Manufacturer
- Manufacturer
- Interacoustics A/S
Sources (1)
- FDA 510(k) K060883 24 fields · synced Sep 24, 2026