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K Number
K961827
Device Name
IN-THE-EAR
Manufacturer
QUALITONE
Date Cleared
1996-07-03

(51 days)

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

Not Found

Device Description

The design follows traditional principles of operation for hearing aid instruments. This device is manufactured and assembled with equivalent manufacturing practices and performance guidelines. Performance of this instrument meets requirements specified by ANSI S-3.22 1987. User controls and methods are similar to other products currently on the market. Sound processing for this instrument is also similar to devices presently marketed by Qualitone.

AI/ML Overview

The provided text is a "Summary of Safety And Effectiveness" for a hearing aid device, K961827, from Qualitone, submitted in 1996. It states that the device is substantially equivalent to existing products and meets the requirements of ANSI S-3.22 1987.

However, the document does not contain the detailed information requested regarding:

  1. Acceptance criteria and reported device performance in a table. It only broadly states "Performance of this instrument meets requirements specified by ANSI S-3.22 1987."
  2. Sample size used for the test set and data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. Multi Reader Multi Case (MRMC) comparative effectiveness study information.
  6. Standalone (algorithm only) performance.
  7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
  8. Sample size for the training set.
  9. How the ground truth for the training set was established.

The document is a regulatory submission summary focused on demonstrating substantial equivalence with existing devices based on traditional design principles, manufacturing practices, and adherence to a specific ANSI standard. It does not provide the results of a detailed study with the specific metrics requested.

Therefore, I cannot populate the requested information from the provided text.

§ 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.