AUDIOTONE (A-552)

• K Number: K965063
• Device Name: AUDIOTONE (A-552)
• Manufacturer: MIRACLE-EAR, INC.
• Date Cleared: 1997-01-27 ( 40 days)
• Product Code: ESD
• Regulation Number: 874.3300
• Type: Traditional
• Panel: EN
• Reference & Predicate Devices: K901745

Intended Use

To amplify and transmit sound to the ear.

Device Description

BTE Hearing Aid

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving that the Audiotone A-552 BTE device meets such criteria. The document is a "Summary of Safety and Effectiveness" which outlines basic device information, classification, intended use, and equivalence to a previously cleared device.

Therefore, I cannot fulfill the request for tables and descriptions regarding acceptance criteria and study details.

The provided text does NOT contain the following information:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) 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 document states: "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." While this specifies a standard used for testing, it does not provide the acceptance criteria (i.e., specific thresholds the device must meet to be deemed acceptable) nor the results of a study demonstrating compliance with those criteria.

Regulation Number and Section

§ 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.