(88 days)
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing.
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing.
The provided text is a 510(k) Pre-market Notification for the Danavox 163 / 162 BTE hearing aids. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving safety and effectiveness through a clinical trial with specific performance criteria.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria in the same way a de novo or PMA submission would.
Here's why and what information can be gleaned:
- Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is achieved by demonstrating that the new device has the same intended use and similar technological characteristics, or, if there are differences, that those differences do not raise new questions of safety or effectiveness.
- Performance Specifications: The document states that "The intended use, performance specifications, functions and operations of the Danavox 163 / 162 BTE are essentially identical to that described in the 510(k) Premarket Notification for the Danavox Aura." This implies the Danavox Aura's performance specifications serve as the de facto acceptance criteria. However, those specific criteria are not detailed in this document.
Information NOT present in the document:
- A table of acceptance criteria and reported device performance (for the 163/162 BTE specifically).
- Sample size for a test set or data provenance.
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance (as this is a hardware device, not an AI/algorithm).
- Type of ground truth used (as there's no clinical study described).
- Sample size for a training set (as there's no machine learning/AI component).
- How ground truth for a training set was established.
Information that can be inferred or extracted (but not in the format requested):
While there are no explicit acceptance criteria or a study detailed in the document, the basis for market clearance is "substantial equivalence." The predicate device's performance specifications are implicitly the target.
Intended Use/Performance Description (from the document):
| Feature/Specification | Danavox 163 / 162 BTE | Predicate Device (Danavox Aura) | Equivalence Claim |
|---|---|---|---|
| Intended Use | Compensates for hearing losses from mild to severe by amplifying sound pressure waves and transmitting the signal to the external ear through air. | Same | Essentially identical |
| Device Type | Air-conduction behind-the-ear hearing instrument with body-worn processor. | Same | Same |
| Power Source | Model 163: type 13 battery. Model 162: type 312 battery. | Not specified, but standard hearing aid batteries expected. | Standard hearing aid batteries |
| Manufacturing | Manufactured and delivered completely assembled using widely used materials and techniques. | Same | Widely used techniques |
| Fitting Parameters | Ability to program digitally. | Same | Same |
| Sound Processing | Ability to change characteristics and adjust volume. | Same | Same |
| Memory Programs | Retains up to three programs. | Retains four programs. | Difference noted, but implies it does not raise new questions of safety/effectiveness as 3 programs is still a functional equivalent for basic use. |
Summary of "Acceptance Criteria" and "Study" based on a 510(k) Submission:
Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to the predicate device, the Danavox Aura (K905692). The "study" proving this is effectively the comparison provided in the summary of safety and effectiveness, which highlights similarities in intended use, technological characteristics, and performance.
- Table of Acceptance Criteria and Reported Device Performance: Such a table is not provided. The document states the performance specifications, functions, and operations are "essentially identical" to the predicate device. The only noted difference is memory capacity (3 programs vs. 4 for the predicate), which was deemed acceptable.
- Sample Size and Data Provenance: Not applicable, as this is a comparison to a predicate device, not a new clinical study.
- Number of Experts and Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable (not an AI device).
- Standalone Performance: The "standalone" performance is understood to be the inherent functionality of the hearing aid, which is asserted to be "essentially identical" to the predicate device. No new standalone performance study is detailed.
- Type of Ground Truth: Not applicable. The "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate device.
- Sample Size for Training Set: Not applicable (not an AI device).
- How Ground Truth for Training Set Was Established: Not applicable (not an AI device).
§ 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.