(50 days)
. 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.
. 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.
The provided document is a summary of safety and effectiveness for the ReSound® Personal Hearing System EDR-7, comparing it to a predicate device for substantial equivalence. It does not describe a study involving acceptance criteria and device performance in the way typically expected for an AI/ML device or a medical device with measurable diagnostic or treatment outcomes evaluated against specific performance metrics.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) because the document does not contain this type of study or information.
Instead, the document focuses on demonstrating substantial equivalence for a hearing aid by comparing its features, intended use, and manufacturing processes to a previously cleared device. Key points from the document indicating this are:
- Substantial Equivalence Statement: "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:"
- Comparison Points: The bullet points describe similarities in:
- Intended use (amplifying sound for hearing loss).
- Power source (standard battery).
- Manufacturing (materials and techniques).
- Performance specifications, functions, and operations.
- Digital programming ability and program retention.
This is a regulatory submission for a traditional medical device demonstrating equivalence, not a performance study as outlined in your request.
§ 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.