(50 days)
No
The description focuses on standard hearing aid technology, digital programming with factory presets, and equivalence to a predicate device without mentioning AI or ML capabilities.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is an air-conduction hearing instrument intended to amplify sound to compensate for hearing loss, which is a compensatory/assistive function rather than a therapeutic one.
No
The device is an air-conduction hearing instrument intended to amplify sound to compensate for hearing loss, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "hearing instrument" that amplifies sound pressure waves and transmits them to the external ear, is powered by a battery, and is manufactured and delivered completely assembled, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an "air-conduction hearing instrument" intended to "amplify sound pressure waves and transmit the signal to the external ear... to compensate for hearing losses."
- No Specimen Analysis: The device does not interact with or analyze any specimens taken from the human body. It works by amplifying external sounds and delivering them to the ear.
Therefore, this device falls under the category of a hearing aid, which is a medical device but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderately-severe.
Product codes
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Device Description
The device is powered by a standard hearing aid battery (type 13). . The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The ability to program digitally the fitting parameters of the hearing device and the ability of the device to retain the program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System ED3-E. Seven programs are factory preset for the EDR-7 from which the dispenser may select for the fitting. The seven factory preset programs may not be modified by the dispenser via a programmer or by any other means. Modifications in the preset programming may only be accomplished at the factory.
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
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Key Metrics
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Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for ReSound Hearing Health Care. The word "ReSound" is written in a bold, serif font, with the "R" and "E" connected. A registered trademark symbol is located to the right of the word. Below the logo, the words "HEARING HEALTH CARE" are written in a smaller, sans-serif font.
APR 1 0 1996
ReSound® Personal Hearing System EDR-7
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence for the ReSound® Personal Hearing System EDR-7 to the predicate device, the ReSound® Personal Hearing System ED3-E. 510(k) No. K950319, February 8, 1995, is based on the following:
- . This air-conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderately-severe.
- The device is powered by a standard hearing aid battery (type 13). .
- The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices.
- The intended use, performance specifications, functions and operations of the ReSound® . Personal Hearing System EDR-7 are substantially equivalent to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System ED3-E.
- . The ability to program digitally the fitting parameters of the hearing device and the ability of the device to retain the program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System ED3-E. Seven programs are factory preset for the EDR-7 from which the dispenser may select for the fitting. The seven factory preset programs may not be modified by the dispenser via a programmer or by any other means. Modifications in the preset programming may only be accomplished at the factory.