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K Number
K955930
Device Name
BELTONE COMPOSER 2000 BTE HP
Manufacturer
BELTONE ELECTRONICS CORP.
Date Cleared
1996-03-01

(71 days)

Product Code
ESD
Regulation Number
874.3300
Type
Traditional
Panel
EN
Reference & Predicate Devices
K933291
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To amplify and transmit sound to the ear

Device Description

The Beltone Composer 2000 BTE HP Air Conduction Hearing Aid is identical to the Maico Gamma RD BTE HP programmable hearing aid (K933291) with the exception of changes to the labeling.

AI/ML Overview

I am sorry, but the provided text describes a hearing aid (Beltone Composer 2000 BTE HP) and its general features, technical characteristics, intended use, and assembly. It does not contain any information about a study, acceptance criteria, or performance metrics in the context of a clinical trial or evaluation.

Therefore, I cannot provide the requested information about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. If an MRMC comparative effectiveness study was done or its effect size.
  6. If a standalone algorithm performance study was done.
  7. The type of ground truth used.
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

The text focuses on establishing substantial equivalence to another hearing aid (Maico Gamma RD BTE HP programmable hearing aid, K933291) based on identical components and compliance with ANSI S3.22-1987 standards for technical specifications. This implies a different type of regulatory submission, likely a 510(k) in the US, where equivalence is demonstrated rather than new clinical trials with detailed performance metrics against specific acceptance criteria.

§ 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.