(166 days)
The InSound XT Hearing Aid is a disposable, extendedwear, air conduction hearing aid, designed to be used and worn by hearingimpaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an ENT physician and it can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal, the hearing aid is discarded.
The InSound XT Series Hearing Device amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The hearing device is extendedwear (up to 4 months) and disposable. It is placed deep in the ear canal by an ENT physician. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| Materials contacting skin meet USB Class 6 requirements and pass testing for antimicrobial, cytotoxicity, irritation, and sensitization. | All materials contacting the skin meet USB Class 6 requirements and additionally passed testing for antimicrobial, cytotoxicity, irritation and sensitization. |
| Device with battery assessed as per ANSI C18 Part 1-1999. | The device with its battery has been assessed as per ANSI C18 Part 1-1999 and passed well within the specifications. |
| Efficacy: | |
| Performance characteristics evaluated in accordance with ANSI S3.22-1996, "Specification of Hearing Aid Characteristics." | The devices met all applicable specifications developed by the manufacturer in accordance with test methods outlined in the specifications. |
| Clinical trials confirm comfort, safety, and efficacy for extended wear. | Clinical trials for the InSound XT devices have confirmed that the hearing aids are comfortable, safe and efficacious for wear in human subjects. |
| Clinical trials validate safe and effective use of accessories and fitting system. | Additionally, the clinical trials validated the safe and effective use of the InSound XT accessories and the wireless hand-held fitting system. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the clinical trials or "test set." It only mentions "human subjects." The data provenance is described as "clinical trials" which are typically prospective studies. The country of origin of the data is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical trials. It does mention that the device is "placed deep in the ear canal by an ENT physician," suggesting that ENT physicians would be involved in the clinical setting and potentially in evaluating the device's performance and comfort.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set or clinical trials.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text, nor is there any discussion of an effect size for human readers improving with AI vs. without AI assistance. This is a hearing aid device, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm only) performance study was done as this is a physical medical device (hearing aid), not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth for the clinical trials appears to be based on:
- Clinical observations and subject feedback: Assessed comfort, safety, and efficacy during extended wear.
- Hearing aid verification battery: Demonstrated user benefit during extended wear.
- Compliance with ANSI standards: Performance characteristics were evaluated against established engineering specifications.
8. Sample Size for the Training Set
The document does not mention a separate "training set" or its sample size. The clinical trials described appear to serve as the evidence for efficacy and safety.
9. How the Ground Truth for the Training Set was Established
As no separate training set is explicitly mentioned, the establishment of ground truth would refer to how the clinical trial outcomes were determined, as described in point 7.
§ 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.