(126 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or specific performance metrics typically associated with AI/ML models. The performance testing methodology is a standard for hearing aids.
Yes
The device is a hearing aid, which is a therapeutic device designed to treat hearing impairment by amplifying and transmitting sound to the ear. The intended use clearly states its function, and the device description lists types of hearing aids.
No
Explanation: The device's intended use is to amplify and transmit sound to the ear, which describes a hearing aid. Hearing aids are assistive devices, not diagnostic devices. The performance studies also mention testing hearing aids.
No
The device description explicitly states "CIC, ITC and ITE Hearing Aids," which are hardware devices. The summary also mentions performance studies using 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 to improve hearing, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The device is described as "CIC, ITC and ITE Hearing Aids." Hearing aids are devices that assist with hearing, not diagnostic tools.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition based on such analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
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
CIC, ITC and ITE Hearing Aids
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 totest 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
K964419 FEB – 4 1997
Summary of Safety and Effectiveness
| Device Name: | Dahlberg Sharp Plus and BILL Hearing Aids |
|---|---|
| Device Type: | CIC, ITC and ITE Hearing Aids |
| Classification: | Air Conduction Hearing Aid (77ESD), Class I. |
| Intended Use: | To amplify and transmit sound to the ear. |
| Substantially | |
| Equivalent to: | Miracle-Ear Sharp Plus canal hearing aids which were |
| cleared for distribution under 510(k) #K935265. | |
| Registration | |
| Number: | 2110592 |
| Materials: | The hearing aid shells 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: | Battery size dependent on hearing aid model. |