(67 days)
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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 description and intended use indicate it is an amplifier for sound, consistent with a hearing aid, rather than a device intended to treat or cure a medical condition. Its predicate device is also a hearing aid.
No
The device is a hearing aid, which is designed to amplify sound for individuals with hearing impairment. Its intended use is to transmit sound to the ear, not to diagnose a condition. The performance studies mentioned relate to testing the hearing aid's performance, not its diagnostic accuracy.
No
The device description explicitly states "Dahlberg Hearing Aid with multi-channel compression circuit," which describes a hardware device. The performance studies also refer to testing "hearing aids" using a standard for hearing aid performance, further indicating 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 lacks any mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition based on such analysis.
- Performance Studies: The performance studies mentioned relate to the acoustic performance of the hearing aid (ANSI S3.22-1987 methodology), which is relevant to its function as a sound amplifier, not its ability to diagnose.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
To amplify and transmit sound to the ear.
Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Mar 3 | 1997
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 BTE hearing aids which were cleared for distribution under document control number K964530. |
| 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 size 13 battery. |