(68 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description is limited to a basic hearing aid function.
Yes
A hearing aid is used to treat hearing loss by amplifying sound, making it a therapeutic device.
No
The device's intended use is to "amplify and deliver sound to the ear," which describes a hearing aid, not a device used for diagnosis.
No
The device is described as a "BTE Hearing Aid," which is a hardware device worn behind the ear. The description does not indicate it is solely software.
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 that analyzes samples from the body to diagnose a condition.
- Device Description: A "BTE Hearing Aid" is a well-known type of medical device used for hearing assistance, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or diagnostic purposes.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures. This device does not fit that description.
N/A
Intended Use / Indications for Use
To amplify and deliver sound to the ear.
Product codes
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Device Description
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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
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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
K9603-788
NOV 27 1996
Image /page/0/Picture/2 description: The image shows the word "oticon" in a bold, sans-serif font. The letters are black against a white background. There is a diamond shape above the "i" in "oticon".
OTICON, 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 of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| NAME OF DEVICE: | PrimoFocus Compact |
|---|---|
| TYPE OF DEVICE: | BTE Hearing Aid |
| INTENDED USE: | To amplify and deliver sound to the ear. |
| FEATURES: | 47 Db HFA gain, single band compression amplifier with dual |
| time constants and variable compression threshold, utilizes class | |
| D output amplifier. | |
| ASSEMBLY: | Assembled from standard electronic hearing aid components |
| mounted together with a custom microchip/hybrid. | |
| TECHNICAL | |
| CHARACTERISTICS: | Technical specifications are in accordance with ANSI Standards |
| S3.22-1987 | |
| FITTING CRITERIA: | Frequency response, compression threshold, gain and SSPL 90 is |
| dictated by individual audiometric and patient history data. | |
| ADJUSTMENTS/ | |
| CONTROLS: | All parameters are adjusted via manual controls. |
| POWER SOURCE: | Standard type 13 battery. |