(35 days)
To amplify and transmit sound to the ear.
Dahlberg Power BTE
Based on the provided document and the nature of the device (a BTE Hearing Aid), this information does not contain the details necessary to answer your request.
Here's why and what's missing:
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Acceptance Criteria & Reported Device Performance: The document provides general characteristics of the device (device type, intended use, materials, assembly, power, fit). It states that Dahlberg "utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." However, it does not list specific acceptance criteria (e.g., minimum gain, maximum output, frequency response within a certain tolerance, distortion levels) or report any specific performance data against such criteria. For example, it doesn't say "Gain at 1000 Hz: 40 dB, Acceptance Criteria: 38-42 dB."
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Study That Proves the Device Meets Acceptance Criteria: Since no specific acceptance criteria or performance data are provided, there is also no description of a study that proves the device meets these criteria. The mention of "ANSI S3.22-1987 methodology" indicates a standardized testing method is used, but not the results or the study design for demonstrating compliance.
Therefore, I cannot populate the table or provide the requested information regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in detailed performance reports, clinical study summaries, or validation protocols, which are not present in this "Summary of Safety and Effectiveness" document for a K964669 submission.
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Appendix B
:
DEC 2 6 1996
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Summary of Safety and Effectiveness
11.000
| Device Name: | Dahlberg Power BTE |
|---|---|
| Device Type: | BTE Hearing Aid |
| Classification: | Air Conduction Hearing Aid (77ESD), Class I. |
| Intended Use: | To amplify and transmit sound to the ear. |
| SubstantiallyEquivalent to: | Miracle-Ear HL BTE which was cleared for distribution underdocument control number K926092. |
| RegistrationNumber: | 2110592 |
| Materials: | The hearing aid cases will be manufactured from materials thatare commonly used in the industry. |
| Assembly: | The hearing aid will be assembled utilizing similar assemblypractices as Dahlberg's current products. |
| TechnicalCharacteristics: | Dahlberg utilizes the ANSI S3.22-1987 methodology to test andobtain performance data for hearing aids. |
| Fit: | Moderate to profound as dictated by the individual usersaudiogram. |
| Power: | Zinc-Air size 675 battery. |
§ 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.