(24 days)
Not Found
No
The summary describes a standard hearing aid and does not mention any AI or ML capabilities. The performance testing is based on a standard ANSI methodology for hearing aids.
Yes.
The device's intended use is to "amplify and transmit sound to the ear," which implies it is a hearing aid used to correct or compensate for hearing impairment, a therapeutic function. Additionally, the predicate device "Miracle-Ear K-AMP Circuits" is associated with hearing aids, further supporting its therapeutic nature.
No
The device is described as amplifying and transmitting sound to the ear, which is a therapeutic function (hearing aid), not a diagnostic one. While performance is measured, it's for the device's main function, not for diagnosing a condition.
No
The device description "Dahlberg K-AMP BTE" and the intended use "To amplify and transmit sound to the ear" strongly suggest a hardware-based hearing aid (Behind-the-Ear). The performance studies referencing ANSI S3.22-1987, a standard for hearing aid performance, further support this. There is no mention of software as the primary or sole 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 (like blood, urine, or tissue) outside the body to diagnose diseases or conditions.
- Device Description: The description "Dahlberg K-AMP BTE" points to a Behind-the-Ear (BTE) hearing aid, which is a medical device for hearing assistance.
- Anatomical Site: The anatomical site is the "ear," which is a part of the human body. IVDs typically analyze samples taken from the body.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Detecting or measuring substances in specimens.
- Providing information for diagnosis, monitoring, or screening.
Therefore, this device, a hearing aid, falls under the category of a medical device, but not an In Vitro Diagnostic device.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
DEC 2 3 1996
Summary of Safety and Effectiveness
| Device Name: | Dahlberg K-AMP 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: | Miracle-Ear K-AMP Circuits which was cleared for distribution |
| under document control number K954941. | |
| Registration | |
| Number: | 2110592 |
| Materials: | The hearing aid cases will be manufactured from materials that |
| are commonly used in the industry. | |
| Assembly: | The hearing aid will be assembled utilizing similar assembly |
| practices as Dahlberg's current products. | |
| 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. |