LogoFDA 510(k) Search
K Number
K974152
Device Name
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
Manufacturer
BERNAFON-MAICO, INC.
Date Cleared
1997-12-15

(41 days)

Product Code
ESD
Regulation Number
874.3300
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: X 1. Slight X 2. Mild 3. Moderate 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat 5. Other Other: 1. Low Tolerance To Loudness 2. 3.

Device Description

OPUS 2 - COMPLETELY - IN - CANAL SERIES ( CIC ) Device Name:

AI/ML Overview

This is a 510(k) premarket notification for a hearing aid, not an AI/ML medical device. Therefore, the information requested (acceptance criteria, study details, expert qualifications, etc.) related to AI/ML device performance is not applicable to this document.

The document discusses the substantial equivalence determination for the "OPUS 2 - COMPLETELY - IN - CANAL SERIES - CIC" hearing aid to legally marketed predicate devices, and its indications for use. It primarily concerns regulatory approval based on existing device classifications and general controls.

There is no information within this document about:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test or training sets, or data provenance.
  • Number or qualifications of experts used for ground truth.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) studies or effect sizes for AI assistance.
  • Standalone algorithm performance.
  • Types of ground truth used (e.g., pathology, outcomes data).
  • How ground truth for a training set was established.

§ 874.3300 Air-conduction hearing aid.

(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.