(40 days)
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No
The summary describes a standard BTE hearing aid and does not mention any AI/ML terms or capabilities.
No
A hearing aid is generally considered a device to compensate for hearing loss, rather than directly treating a medical condition like a therapeutic device would. Its primary function is to amplify sound, not to cure or alleviate a disease or injury.
No
This device is described as a "BTE Hearing Aid" with the intended use "To amplify and transmit sound to the ear." This function is for sound amplification, not for diagnosing a medical condition.
No
The device description explicitly states "BTE Hearing Aid," which is a hardware device. The intended use also describes amplifying and transmitting sound, which requires hardware components.
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 derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: It's described as a "BTE Hearing Aid," which is a well-established category of medical device for hearing assistance.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information based on laboratory tests
The information provided clearly points to a hearing aid, which is a medical device but not an IVD.
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)
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
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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
JAN 27 1997
Appendix B
K965057
Summary of Safety and Effectiveness
| Device Name: | Audiotone A-554H 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-54SR which was cleared for distribution |
| under document control number K941122. | |
| 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. |