(15 days)
Not Found
No
The summary describes a standard hearing aid with a multi-channel compression circuit and references a predicate device with similar technology. There is no mention of AI, ML, or related concepts.
No.
The device is a hearing aid, which amplifies sound for the ear. While it assists with a medical condition (hearing loss), its primary function is amplification rather than direct therapy or treatment of the underlying condition itself. Therapeutic devices often involve active treatment or monitoring of disease.
No
Explanation: The device's intended use is to amplify and transmit sound to the ear, and it is described as a hearing aid. This functionality is for assisting hearing, not diagnosing a medical condition.
No
The device description explicitly states "Dahlberg Hearing Aid with multi-channel compression circuit," which indicates a physical hardware device designed to amplify and transmit sound. The summary also mentions performance testing using ANSI S3.22-1987, a standard for hearing aid performance, further confirming it is a hardware device.
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 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 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 information for diagnosis, monitoring, or screening of diseases or conditions
The information provided aligns with the description of a medical device used for treatment (hearing assistance), not for in vitro diagnostic testing.
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
Dahlberg Hearing Aid with multi-channel compression circuit
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 to test 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
NOV 27 1996
Summary of Safety and Effectiveness
| Device Name: | Dahlberg Hearing Aid with multi-channel compression circuit |
|---|---|
| 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: | Dahlberg multi-channel compression hearing aids which were |
| cleared for distribution under document control number | |
| K960804. | |
| 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. |