(63 days)
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No
The device description explicitly states it follows traditional principles and manufacturing, and there are no mentions of AI, ML, or related concepts.
No
The device is described as a 'Hearing Aid', and its performance meets ANSI S3.2-1987 standards, which are typically for hearing aids. While hearing aids address hearing impairment, a medical condition, they are generally considered assistive devices rather than therapeutic devices designed to cure or treat the underlying cause of the condition.
No
Explanation: The device description explicitly states it is a "Hearing Aid" and "follows traditional principles of operation for Hearing Aids," which are compensatory devices, not diagnostic ones. Furthermore, there is no mention of it being used to detect, diagnose, or monitor a disease or condition. The performance study refers to ANSI S3.2-1987, which is a standard for personal hearing aids.
No
The device description explicitly states it is "manufactured and assembled," implying the presence of hardware components, which contradicts the definition of a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description clearly states the device is a Hearing Aid. Hearing aids are devices that amplify sound to help people with hearing loss. They interact with the external environment and the user's ear, not with internal bodily specimens.
- The description mentions it follows "traditional principles of operation for Hearing Aids" and meets performance requirements for hearing aids (ANSI S3.2-1987).
Therefore, the function and nature of this device are entirely outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The design follows traditional principles of operation for Hearing Aids. The device is manufactured and assembled with equivalent manufacturing practices and performance guidelines.
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
Performance of this instrument meets requirements specified by ANSI S3.2-1987.
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
Ethical Hearing Instrument Portsmouth. 0 Fleet Str
JAN 2 4 1997
国际
Safety and Effectiveness DRAERD 510 (k) Summary/Statement Certification for Ethical ComfortAid Hearing Aid.
The summary of information, new product to present products demonstrates substantial equivalence as required by the "Safe Medical Devices Act (SMDA)" of 1990. The design follows traditional principles of operation for Hearing Aids. The device is manufactured and assembled with equivalent manufacturing practices and performance guidelines. Performance of this instrument meets requirements specified by ANSI S3.2-1987. User controls and methods are similar to others currently being marketed.