(40 days)
Not Found
No
The summary describes a standard BTE hearing aid and does not mention any AI or ML terms, image processing, or details about training/test sets typically associated with AI/ML devices.
No.
The intended use is to amplify and transmit sound, and the device is described as a BTE Hearing Aid, which primarily aids hearing and is not typically classified as a therapeutic device.
No
The device, a BTE Hearing Aid, is described as amplifying and transmitting sound, which are functions of sound assistance rather than diagnosis. The predicate device's clearance also indicates an assistive function.
No
The device is described as a "BTE Hearing Aid," which is a hardware device worn behind the ear. The summary also mentions performance studies utilizing a methodology for testing hearing aids, further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To amplify and transmit sound to the ear." This describes a device that interacts with the body (the ear) to improve hearing, not a device used to examine specimens from the body (like blood, urine, or tissue) to diagnose diseases or conditions.
- Device Description: It is described as a "BTE Hearing Aid." Hearing aids are devices that assist with hearing, not diagnostic tools that analyze biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening. This device clearly operates in vivo (within the body) to improve hearing.
N/A
Intended Use / Indications for Use
To amplify and transmit sound to the ear.
Product codes (comma separated list FDA assigned to the subject device)
77ESD
Device Description
BTE Hearing Aid
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Appendix B
JAN 2 7 1997
Summary of Safety and Effectiveness
| Device Name: | Audiotone A-554 BTE |
|---|---|
| Device Type: | BTE Hearing Aid |
| Classification: | Air Conduction Hearing Aid (77ESD), Class I |
| Intended Use: | To amplify and transmit sound to the ear. |
| Substantially Equivalent to: | Audiotone model A-54 which was cleared for distribution under document control number K941121. |
| Registration Number: | 2110592 |
| Materials: | The hearing aid cases will be manufactured from materials that are commonly used in the industry. |
| Technical Characteristics: | Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids. |
| Fit: | Mild to severe as dictated by the individual users audiogram. |
| Power: | Zinc-Air size 13 battery |
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