(40 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The description is limited to basic hearing aid function and standard performance testing.
Yes
The device is a BTE Hearing Aid, which is used to amplify sound for individuals with hearing impairment, making it a therapeutic device.
No
The device, a BTE Hearing Aid, is described as amplifying and transmitting sound to the ear, which is a therapeutic function for hearing improvement rather than a diagnostic function of identifying or characterizing 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 screening.
- Device Description: It's described as a "BTE Hearing Aid," which is a well-established category of medical device for hearing assistance, not for in vitro diagnostic testing.
- Anatomical Site: The anatomical site is the "ear," which is where the device is used on the body, not where a specimen is collected from.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the information clearly indicates a device for amplifying sound for hearing, which falls under the category of a hearing aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To amplify and transmit sound to the ear.
Product codes
77ESD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 4 1997
K96 5063
Summary of Safety and Effectiveness
| Device Name: | Audiotone A-552 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-52S which was cleared for distribution under document control number K901745. |
| 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. |