(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 devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Severity:
X 2. Mild
X 3. Moderate
X 4. Severe
Configuration:
X 1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
X 3. Reverse Slope
X 4. Flat
Other
X 1. Low tolerance To Loudness
This air-conduction behind-the-ear hearing instrument with body-worn processor 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 severe.
The device is powered by a standard hearing aid battery (type 13) and 2 standard alkaline type AAA batteries.
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 Audallion® III Hearing System are essentially identical to that described in the 510(k) Premarket Notification for the Danavox Aura.
The ability to program digitally the fitting parameters of the hearing device is the same as in the Danavox Aura as is the ability to change the characteristics of the sound processing and adjust the volume.
The Audallion® III Hearing System has the ability to retain up to four programs in memory, iust as the predicate device.
The provided document is a 510(k) premarket notification for the Audallion® III Hearing System. It is a declaration of substantial equivalence to a predicate device, the Danavox Aura 510(k) No. K905692. This type of submission does not typically include a standalone study proving the device meets specific acceptance criteria in the way a clinical trial for a novel device would.
Instead, the submission relies on demonstrating that the Audallion® III Hearing System is substantially equivalent to a device that has already been cleared by the FDA. Therefore, the "acceptance criteria" here are met by showing that the new device shares the same intended use, performance specifications, functions, and operations as the predicate device.
Here's an analysis based on your request, highlighting what's present and what's absent due to the nature of a 510(k) substantial equivalence submission:
Acceptance Criteria and Device Performance for Audallion® III Hearing System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated by Substantial Equivalence to Predicate) | Reported Device Performance (as claimed by substantial equivalence) |
|---|---|
| Intended use is 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 severe. | Intended use: 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 severe. |
| Device is powered by a standard hearing aid battery (type 13) and 2 standard alkaline type AAA batteries. | Device is powered by a standard hearing aid battery (type 13) and 2 standard alkaline type AAA batteries. |
| Device is manufactured and delivered completely assembled using widely used materials and techniques. | Device is manufactured and delivered completely assembled using materials and techniques widely used by other manufacturers of hearing devices. |
| Performance specifications, functions, and operations are essentially identical to the Danavox Aura. | Performance specifications, functions, and operations are essentially identical to the Danavox Aura. |
| Ability to program digitally the fitting parameters. | Ability to program digitally the fitting parameters is the same as in the Danavox Aura. |
| Ability to change the characteristics of sound processing and adjust volume. | Ability to change the characteristics of sound processing and adjust volume is the same as in the Danavox Aura. |
| Ability to retain up to four programs in memory. | Ability to retain up to four programs in memory, just as the predicate device (Danavox Aura). |
| Indicated for specific hearing loss configurations (High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat). | Indicated for High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat hearing loss configurations. |
| Indicated for specific hearing loss severities (Mild, Moderate, Severe). | Indicated for Slight, Mild, Moderate, Severe hearing loss severities (though "slight" is crossed out in the document, it's checked off). |
| Indicated for low tolerance to loudness. | Indicated for low tolerance to loudness. |
2. Sample size used for the test set and the data provenance
This information is not provided in the 510(k) summary. A substantial equivalence submission typically does not require new clinical or performance studies if the device is sufficiently similar to a predicate device. The "test set" in this context is the comparison against the specifications and features of the predicate device, not necessarily a new test set for the Audallion III.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. As explained above, the "ground truth" for a 510(k) is the established performance and safety of the predicate device, which has been previously cleared by the FDA. No new expert panel for establishing ground truth for the Audallion III is mentioned.
4. Adjudication method for the test set
This information is not provided. The comparison is a regulatory review process conducted by the FDA, assessing whether the new device falls within the scope of the predicate device's cleared status.
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
An MRMC study is not applicable and not mentioned. The Audallion® III Hearing System is an air-conduction hearing aid, not an AI-assisted diagnostic or interpretative system that would involve "human readers" in the context of an MRMC study.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This information is not applicable and not provided. The device is a hearing aid, which is a physical device that continuously processes sound for the wearer, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a 510(k) submission, the "ground truth" is established by the prior FDA clearance and historical safety and effectiveness data of the predicate device, the Danavox Aura. The Audallion III is deemed safe and effective because it is substantially equivalent to a device already deemed safe and effective.
8. The sample size for the training set
This information is not applicable and not provided. As a hardware medical device submitting for 510(k) clearance based on substantial equivalence, there is no "training set" in the context of machine learning or AI algorithms used in the device's development as described in the document.
9. How the ground truth for the training set was established
This information is not applicable and not provided. See point 8.
In summary: The provided document is a 510(k) premarket notification of intent to market based on substantial equivalence. It is not a clinical study report. Therefore, it focuses on demonstrating that the new device (Audallion® III) is essentially the same as a previously cleared device (Danavox Aura) in terms of intended use, technology, and performance specifications. The "acceptance criteria" are the features and performance of the predicate device, which the Audallion® III is claimed to match. This type of submission generally does not require new de novo clinical studies or detailed data analysis as would be expected for a novel device or an AI-powered diagnostic.
§ 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.