(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.
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AX (908) 560-002
This 510(k) summary safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
C 12 1998
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
NAME OF DEVICE: DigiFocus ITE (DFI) TYPE OF DEVICE: In the Ear Hearing Aid INTENDED USE: To amplify and deliver sound to the ear DigiFocus is a seven band, two channel fully automatic FEATURES: 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 ASSEMBLY: components mounted together with custom microchips on flexfilm. ア TECHNICAL Technical specifications are in accordance with ANSI Standards S3.22-1987. CHARACTERISTICS: FITTING CRITERIA: Frequency response, compression threshold and ratio, gain and SSPL 90 is dictated by individual audiometric and patient history data. ADJUSTMENTS/ All parameters are digitally programmed via OtiSet software using the standard NOAH platform. The hearing CONTROLS: aid may have an optional T-M switch. Standard size 312 battery. POWER SOURCE: A USER INSTRUCTIONAL BROCHURE, INCLUDING ANSI TECHNICAL DATA IS SUPPLIED WITH EACH HEARING AID.
§ 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.