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A. General: 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 catage(fes). (Check appropriate space(s)): Severity: Mild, Moderate. Configuration: Flat.
B. Specific (List Claims): Not Found

AIR CONDUCTION HEARING AID (BC-H2000)

This document is a 510(k) premarket notification decision letter from the FDA for an Air Conduction Hearing Aid (Model PC-H2000). It primarily addresses the device's substantial equivalence to existing devices and provides regulatory guidance. As such, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes for test and training sets, data provenance.
• Details on expert involvement for ground truth establishment.
• Adjudication methods.
• Comparisons to human readers (MRMC study).
• Standalone algorithm performance.
• Types of ground truth used.
• How ground truth for the training set was established.

The document only states the "Indications For Use" for the hearing aid, which includes amplifying sound for individuals with impaired hearing, specifically for "mild" and "moderate" severity losses and a "flat" configuration. These are indications for use, not quantitative acceptance criteria with performance metrics.

The letter mentions that "Most psycho/acoustic claims, including those pertaining to the understanding of speech in noise, must be supported by clinical data," suggesting that such data would typically be part of a submission for those claims, but this document does not contain that data or its analysis.

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