(20 days)
To amplify and deliver sound to the ear
DigiFocus is a seven band, two channel fully automatic hearing instrument which utilizes true digital signal processing (DSP). True DSP allows for precise, seven band frequency shaping and a unique and complex compression system utilizing syllabic compression in the lower frequency channel (below 1500 Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 42 dB HFA gain. Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm.
It appears the provided text is a summary of safety and effectiveness information for a hearing aid device called "DigiFocus ITE (DFI)". However, the information details the device's technical specifications, intended use, and features but does not contain any information about acceptance criteria, study data, or performance outcomes.
Therefore, I cannot provide the requested information, as the provided text lacks the necessary content to answer questions regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The text focuses on the device's technical characteristics and how it functions as a hearing aid, rather than a clinical study evaluating its performance 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.