(50 days)
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No
The summary describes standard digital hearing aid technology with programmable parameters, but there is no mention of AI or ML capabilities.
Yes
The device is intended to compensate for hearing losses by amplifying sound, which is a therapeutic function.
No
Explanation: The device is described as an air-conduction hearing instrument intended to amplify sound and compensate for hearing loss, indicating it is a therapeutic or assistive device, not one used for diagnosis.
No
The device description explicitly states it is a "hearing instrument" powered by a "standard hearing aid battery (type 13)" and is "manufactured and delivered completely assembled," indicating 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 sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses." This describes a device that interacts with the body to improve a physical function (hearing), not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical components and function of a hearing aid, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device works by amplifying sound, which is an external physical phenomenon.
Therefore, this device falls under the category of a medical device that directly interacts with the patient's body for therapeutic or compensatory purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These air-conduction hearing instruments are 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 (comma separated list FDA assigned to the subject device)
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Device Description
These devices are powered by a standard hearing aid battery (type 13). These devices are 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 devices and the ability of the devices to retain one program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System ED3-E. The EDR-E, EDR-ES, and EDR-EV are dispenser programmable, whereas the EDR-P1 programming is factory preset and may be reprogrammed at the factory only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ReSound® Personal Hearing System ED3-E, 510(k) No. K950319
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
KIUoloSC
Image /page/0/Picture/1 description: The image shows the logo for ReSound Hearing Health Care. The logo is in black and white, with the word "ReSound" in a bold, serif font. The registered trademark symbol is to the right of the word. Below the word "ReSound" is the phrase "HEARING HEALTH CARE" in a smaller, sans-serif font.
APR 1 0 1996
ReSound® Personal Hearing Systems EDR Encore Series
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence for the ReSound® Personal Hearing Systems EDR Encore Series: Models EDR-E, EDR-ES, EDR-EV, and EDR-P1 to the predicate device, the ReSound® Personal Hearing System ED3-E, 510(k) No. K950319, February 8, 1995, is based on the following:
- . These air-conduction hearing instruments are 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.
- . These devices are powered by a standard hearing aid battery (type 13).
- . These devices are 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 Systems EDR Encore Series 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 devices and the ability of the devices to retain one program, even when the main battery is removed and changed, is the same as in the ReSound® Personal Hearing System ED3-E. The EDR-E, EDR-ES, and EDR-EV are dispenser programmable, whereas the EDR-P1 programming is factory preset and may be reprogrammed at the factory only.