(35 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description and performance studies are consistent with traditional hearing aid technology.
No
The device is described as amplifying and transmitting sound to the ear, and the predicate device is a hearing aid, which is a compensatory device rather than a therapeutic one designed to cure or treat a disease.
No
Explanation: The device's intended use is to amplify and transmit sound, which is a therapeutic function for hearing, not a diagnostic one. The performance studies mentioned relate to hearing aid testing, not diagnostic accuracy.
No
The device description "Dahlberg Power BTE" and the performance study referencing "hearing aids" and "ANSI S3.22-1987" (a standard for hearing aid performance) strongly indicate a hardware-based hearing aid, not a software-only 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 diagnose diseases or conditions.
- Device Description: "Dahlberg Power BTE" describes a type of hearing aid, which is a medical device but not an IVD.
- 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 based on sample analysis.
The information provided clearly points to a hearing aid, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
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)
Not Found
# Device Description
The hearing aid cases will be manufactured from materials that are commonly used in the industry. The hearing aid will be assembled utilizing similar assembly practices as Dahlberg's current products.
# 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.
[K926092](https://510k.innolitics.com/search/K926092)
# 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 6 1996
.
Summary of Safety and Effectiveness
11.000
| Device Name: | Dahlberg Power 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 HL BTE which was cleared for distribution under |
| document control number K926092. | |
| 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: | Moderate to profound as dictated by the individual users |
| audiogram. | |
| Power: | Zinc-Air size 675 battery. |