(60 days)
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Not Found
No
The description focuses on battery life and standard components, with no mention of AI or ML.
Yes
The device is described as a "hearing aid," which is used to amplify sound for individuals with hearing impairment, thereby providing therapy for their condition.
No
The device description states its purpose is "To amplify and transmit sound to the ear," indicating it is a hearing aid, which assists hearing rather than diagnosing a condition.
No
The device description explicitly states it is a "full shell hearing aid utilizing a 675 battery and a low drain class D circuit," indicating it is a hardware device with electronic components.
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 details a hearing aid, which is a medical device designed to assist with hearing loss. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not contain any of the typical indicators of an IVD, such as:
- Mention of analyzing biological specimens.
- Mention of diagnostic purposes based on sample analysis.
- Information about reagents, assays, or laboratory procedures.
Therefore, the Rexton Long Life Rx-12 is a hearing aid, which is a medical device, but it does not fit the definition of 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)
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Device Description
The Rexton Long Life Rx-12 is a full shell hearing aid utilizing a 675 battery and a low drain class D circuit. The combination of these to unique features gives the Rexton Long Life the ease of battery handling (a large 675 battery) and the benifits of extended battery life. These two features should make for a special product with-in the industry.
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
ear
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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
Image /page/0/Picture/0 description: The image shows a handwritten text. The text is written in a cursive style. The letters are not very clear, but it appears to be a word or a short phrase. The background is white.
Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters. The characters appear to be 'K9600295'. The handwriting is somewhat stylized, with some characters connected and others distinct. The overall impression is that of a quickly written or stylized number.
A SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Name of Device: | Rexton's Long Life Rx-12 hearing aid. |
|---|---|
| Type of Device: | In The Ear Hearing Aid - Substantially equivalent to other In The Ear |
| (ITE) hearing aids. | |
| Intended Use: | To amplify and transmit sound to the ear. |
| Features: | The Rexton Long Life Rx-12 is a full shell hearing aid utilizing a 675 |
| battery and a low drain class D circuit. The combination of these to unique | |
| features gives the Rexton Long Life the ease of battery handling | |
| (a large 675 battery) and the benifits of extended battery life. These two | |
| features should make for a special product with-in the industry. | |
| Assembly: | Assembled from standard components which are widely utilized by other |
| hearing aid manufacturers. | |
| Technical | |
| Characteristics: | Technical specifications were obtained in accordance with S3.22-1987 |
| ANSI Specifications. | |
| Preliminary data sheets for the Rexton Long Life RX-12 models are | |
| enclosed. | |
| Fit: | The frequency response of this product is dictated by the individual |
| audiogram from each client. | |
| Power: | Standard hearing aid battery, 675. |
A user's manual and other information is supplied with each hearing aid.