(68 days)
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No
The document describes standard digital hearing aid technology with programmable parameters, but there is no mention of AI or ML capabilities.
Yes
The device is described as "hearing instruments intended to amplify and transmit sound to the ear" for "hearing losses from mild to moderately-severe," which directly addresses a health condition (hearing loss) by improving sound perception.
No
The device is described as an "air-conduction hearing instrument" designed to "amplify and transmit sound to the ear," which indicates it is a therapeutic or assistive device, not one used for diagnosis.
No
The device description explicitly states it is a "hearing instrument" and is "powered by a standard hearing aid battery (type 13)," indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "amplify and transmit sound to the ear" for hearing loss. This is a functional device for hearing, not a test performed on biological samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical characteristics, power source, and programming capabilities of a hearing aid. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or diagnostic tests.
Therefore, this device is a hearing instrument, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, . are designed 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 BT2-E. The BT2-ES and BT2-EV are dispenser programmable, whereas the BT241 programming is factory preset and may be reprogrammed at the factory only.
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
hearing aid dispenser
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): 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.
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.
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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).
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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.
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Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters, which appears to be a code or identifier. The sequence is "K960052". The characters are written in a cursive style with thick, dark strokes, suggesting the use of a marker or pen. The background is plain white, providing a clear contrast for the characters to stand out.
Image /page/0/Picture/1 description: The image shows the logo for ReSound Hearing Health Care. The word "ReSound" is written in a bold, sans-serif font, with the "R" slightly larger than the other letters. The words "HEARING HEALTH CARE" are written in a smaller, sans-serif font below the word "ReSound".
ReSound® Personal Hearing System BT2-ES, BT2-EV, and BT241
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence for the ReSound® Personal Hearing Systems BT2-EV, and BT241 to the predicate device, the ReSound® Personal Hearing System BT2-C, (marketed as the BT2-E Encore), 510(k) No. K943788, September 21, 1994, is based on the following:
- These air-conduction hearing instruments, intended to amplify and transmit sound to the ear, . are designed 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 BT2-ES, BT2-EV, and BT241 are substantially equivalent to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System BT2-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 BT2-E. The BT2-ES and BT2-EV are dispenser programmable, whereas the BT241 programming is factory preset and may be reprogrammed at the factory only.