(50 days)
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.
I am sorry, but the provided text from the "ReSound® Personal Hearing Systems EDR Encore Series" document is a summary of safety and effectiveness for a medical device (hearing aids) and does not contain the specific information required to answer your request.
The text describes:
- The product: ReSound® Personal Hearing Systems EDR Encore Series (Models EDR-E, EDR-ES, EDR-EV, and EDR-P1).
- Its predicate device: ReSound® Personal Hearing System ED3-E.
- Its intended use: To amplify sound for mild to moderately-severe hearing loss.
- Its power source: Standard hearing aid battery (type 13).
- Manufacturing details: Assembled using common techniques and materials.
- Key features: Digital programming ability and program retention.
- Differences in programming: EDR-E, EDR-ES, EDR-EV are dispenser programmable; EDR-P1 is factory preset.
It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Information about standalone algorithm performance tests.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore, I cannot fulfill your request based on the provided input.
§ 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.