(50 days)
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No
The description focuses on traditional digital signal processing (DSP) and programmable parameters based on patient data, without mentioning AI or ML algorithms for learning or adaptation.
No
The device is described as a hearing instrument to amplify and deliver sound to the ear, which addresses hearing impairment rather than treating a disease or condition in a therapeutic manner.
No
Explanation: The device description states its purpose is to "amplify and deliver sound to the ear," which is a therapeutic function for hearing loss, not a diagnostic one. It does not mention any ability to identify, detect, or monitor a disease or condition. The parameters are "dictated by individual audiometric and patient history data," implying it is programmed based on external diagnostic information, not generating it.
No
The device description explicitly states it is a "hearing instrument" assembled from "standard electronic hearing aid components mounted together with custom microchips on flexfilm." This indicates it is a physical hardware device, not software only.
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 from the body to provide diagnostic information.
- Device Description: The description details a hearing instrument with components like microphones, amplifiers, and speakers. This aligns with the function of a hearing aid, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition based on laboratory testing.
IVDs are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device clearly falls outside of that definition.
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 1500Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 54 dB HFA gain.
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
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Key Metrics
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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
K461059/1
/A
MAY - 7 1996
S hen ;
ticon
TICON. INC. 29 Schoolhouse Road P.O. Box 6724 Somerset, NJ 08875-6724 Toll-Free 1-800-526-3921 FAX (908) 560-0029
This 510(k) summary safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
ﺮ ﺍﻟﻤﻮ SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| NAME OF DEVICE: | DigiFocus Compact (DFC) |
|---|---|
| TYPE OF DEVICE: | Behind The Ear Hearing Aid |
| INTENDED USE: | To amplify and deliver sound to the ear |
| FEATURES: | 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 1500Hz) and nonsyllabic | |
| compression in the higher frequency channel (above | |
| 1500Hz). 54 dB HFA gain. | |
| ASSEMBLY: | Assembled from standard electronic hearing aid |
| components mounted together with custom microchips on | |
| flexfilm. | |
| TECHNICAL | |
| CHARACTERISTICS: | Technical specifications are in accordance with ANSI |
| Standards S3.22-1987. | |
| FITTING CRITERIA: | Frequency response, compression threshold and ratio, gain |
| and SSPL 90 is dictated by individual audiometric and | |
| patient history data. | |
| ADJUSTMENTS/ | |
| CONTROLS: | All parameters are digitally programmed via software. |
| The hearing aid has a manual OTM switch. | |
| POWER SOURCE: . | Standard type 13 battery. |