(20 days)
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No
The description focuses on digital signal processing (DSP) and compression techniques, which are standard audio processing methods and do not inherently indicate AI/ML. There are no mentions of AI, ML, or related concepts.
Yes
The device is described as a "hearing instrument" that amplifies and delivers sound to the ear, implying it is used to alleviate hearing impairment, which is a therapeutic purpose.
No
Explanation: The device is described as a "hearing instrument" designed to "amplify and deliver sound to the ear," indicating its function is to assist hearing rather than diagnose a medical condition. It utilizes digital signal processing and compression for sound modification.
No
The device description explicitly states it is "Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm," indicating it is a hardware device with embedded software, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To amplify and deliver sound to the ear." This describes a device that interacts with the body to improve hearing, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a hearing instrument that processes sound. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the DigiFocus hearing instrument is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
To amplify and deliver sound to the ear
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
ear
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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.