(44 days)
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: Mild, Moderate. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low tolerance To Loudness.
The ReSound® Stealth CIC, a completely-in-the-canal hearing device, is an air-conduction hearing instrument, intended to amplify and transmit sound to the ear. The device is powered by a standard hearing aid battery (type 5A). The device is a completely in-the-canal one-channel device with K-Amp™ technology.
This document is a 510(k) premarket notification for the ReSound® Stealth CIC hearing device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, many of the requested details about acceptance criteria and study particulars are not explicitly available or applicable in the provided text.
Here's an attempt to extract and infer the information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format typically seen with clinical studies. Instead, it defines the device's characteristics and functionality and claims substantial equivalence to a predicate device (Philips XP CIC, 510(k) No. K921725). The "acceptance criteria" here are implicitly centered around these equivalence claims.
| Acceptance Criteria (Implied from Equivalence Claims) | Reported Device Performance (as stated in the document) |
|---|---|
| Effectiveness: Capable of amplifying and transmitting sound to the ear for hearing losses from mild to moderate up to 70 dB HL. | "The effectiveness of this air-conduction hearing instrument, intended to amplify and transmit sound to the ear, is equivalent to devices of the same type designed for hearing losses from mild to moderate up to 70 dB HL." (Claim of equivalence) |
| Power Source: Uses a standard hearing aid battery. | "The device is powered by a standard hearing aid battery (type 5A)." |
| Manufacturing/Delivery: Manufactured and delivered assembled using common materials and techniques. | "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." |
| Intended Use, Performance Specifications, Functions, Operations: Substantially equivalent to the predicate device. | "The intended use, performance specifications, functions and operations of the ReSound® Stealth CIC is substantially equivalent to the predicate device." (Claim of equivalence) |
| Device Type: Completely in-the-canal, one-channel, with K-Amp™ technology. | "The device is a completely in-the-canal one-channel device with K-Amp™ technology." |
| Safety: Maximum SSPL90 of less than 132 dB SPL, equivalent to devices of the same type. | "The safety of this device is equivalent to devices of the same type with maximum SSPL90 of less than 132 dB SPL." (Claim of equivalence) |
| Fitting Requirement: Requires deep canal impression. | "Proper fitting of this hearing aid (deep canal aid) requires the taking of a deep canal impression." (This is a user instruction, not a performance criterion per se, but part of safe use). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific "test set" for a clinical study with a sample size or data provenance. The basis for substantial equivalence is primarily through comparison to an existing predicate device and its known performance, along with specific design characteristics of the new device. No new clinical study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no new clinical test set was used to establish ground truth, no experts were involved in this capacity for the purpose of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new clinical test set was used, so no adjudication method was employed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a hearing aid, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hearing aid, which by its nature operates "with human-in-the-loop" (the wearer). There is no standalone algorithm performance that would be separated from human interaction in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence relies on:
- Performance specifications of the predicate device: The Philips XP CIC (K921725) sets the benchmark for performance, safety, and intended use as a legally marketed device.
- General understanding of hearing aid technology: The principles of amplification, power sources, manufacturing, and safety (e.g., maximum SSPL90) are established standards in the field.
- Engineering and design documentation: The internal data supporting the device's specifications (e.g., one-channel, K-Amp™ technology, battery type, SSPL90 levels) would have been used to demonstrate that it meets the expected performance characteristics comparable to the predicate.
8. The sample size for the training set
Not applicable. This submission does not describe a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.