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The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Severity:
_ 1. Light
_ 2. Mild
X 3. Moderate
_ 4. Severe
_ 5. Profound
Configuration:
_ 1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
_ 3. Reverse Slope
_ 4. Flat
_ 5. Other
Other
_ 1. Low tolerance To Loudness
_ 2.
_ 3.

HI-68E, HI-69N and HI-69P are air conduction hearing aids.

This document is a 510(k) premarket notification decision letter from the FDA for Rockwin Corporation's HI-69E, HI-69N, and HI-69P hearing aids. While the letter confirms substantial equivalence to a predicate device and allows marketing, it does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on:

• Regulatory classification: Class I device (21 CFR 874.3300/Procode: 77 ESD).
• Substantial equivalence determination: The FDA found the device substantially equivalent to devices marketed before May 28, 1976.
• General controls: Reminds the manufacturer of requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding/adulteration.
• Potential electromagnetic interference (EMI) concern: Advises the manufacturer of the increasing concern regarding EMI from digital cellular telephones and other sources, and encourages labeling modification to inform users. It also states that any claims of EMI compatibility would require a 510(k) submission with supporting data.
• Indications for Use: The devices are indicated to amplify sound for individuals with impaired hearing, specifically for mild and moderate severity with a gradually sloping configuration of hearing loss.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance as this information is not present in the provided document. A 510(k) submission typically includes summaries of performance data, but the decision letter itself does not detail the specific criteria or the studies used to meet them.

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