(37 days)
Not Found
No
The summary describes a standard hearing aid with a multi-channel compression circuit and references a predicate device from 1995. There is no mention of AI, ML, or related concepts.
Yes
The device is a hearing aid, which amplifies sound to the ear to improve hearing, addressing a medical condition (hearing loss).
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, as they do not identify or characterize a disease or condition.
No
The device description explicitly states "Dahlberg Hearing Aid with multi-channel compression circuit," indicating a hardware component (the hearing aid itself) is part of the device.
No, 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 description "Dahlberg Hearing Aid with multi-channel compression circuit" clearly identifies it as a hearing aid, which is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The provided information lacks any mention of:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or other materials typically associated with IVD testing
Hearing aids are considered medical devices, but they fall under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
To amplify and transmit sound to the ear.
Product codes
77ESD
Device Description
CIC, ITC or ITE 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
The Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids.
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
K96 C804
Appendix B
APR - 5 196
Summary of Safety and Effectiveness
| Device Name: | Dahlberg Hearing Aid with multi-channel compression circuit |
|---|---|
| Device Type: | CIC, ITC or ITE Hearing Aid |
| Classification: | Air Conduction Hearing Aid (77ESD), Class I. |
| Intended Use: | To amplify and transmit sound to the ear. |
| Substantially | |
| Equivalent to: | Dahlberg K-AMP hearing aids which were cleared for |
| distribution under document control number K954941. | |
| Registration | |
| Number: | 2110592 |
| Materials: | The hearing aid shells 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 battery size dependent on hearing aid model. |