(51 days)
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No
The device description explicitly states that the design and sound processing are similar to traditional and currently marketed hearing aids, with no mention of AI or ML.
Yes
The device is described as a "hearing aid instrument," and hearing aids are considered therapeutic devices because they treat hearing impairment.
No
The device description states it follows "traditional principles of operation for hearing aid instruments" and its "sound processing" is "similar to devices presently marketed by Qualitone." Hearing aids are assistive devices that amplify sound, not diagnostic devices that identify or characterize a disease or condition. There is no information suggesting it performs any diagnostic function.
No
The device description explicitly states it is "manufactured and assembled" and refers to "hardware components" and "sound processing for this instrument," indicating it is a physical hearing aid, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on the device's function as a hearing aid, which is an in vivo (within the body) device. There is no indication that it is used to examine specimens derived from the human body for diagnostic purposes.
- Focus on hearing aid function: The description explicitly states it follows "traditional principles of operation for hearing aid instruments" and meets performance requirements for hearing aids.
- Lack of IVD-specific information: The document lacks any of the typical information found in descriptions of IVDs, such as intended use for diagnosing a specific condition, sample types, or performance metrics related to diagnostic accuracy.
Therefore, based on the provided text, this device is a hearing aid and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The design follows traditional principles of operation for hearing aid instruments. This device is manufactured and assembled with equivalent manufacturing practices and performance guidelines.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of this instrument meets requirements specified by ANSI S-3.22 1987.
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 is a logo for Qualitone. The logo features a globe inside of a circle on the left side of the image. To the right of the globe is the word "QUALITONE" in large, bold letters. Underneath the word "QUALITONE" is the phrase "HEARING AIDS & AUDIOMETERS • WORLDWIDE".
JUL - 3 1986
Summary of Safety And Effectiveness for DSD K-AMP Option
The summary of information, new product to present products demonstrates substantial equivalence as required by the "Safe Medical Devices Act (SMDA)" of 1990. The design follows traditional principles of operation for hearing aid instruments. This device is manufactured and assembled with equivalent manufacturing practices and performance guidelines. Performance of this instrument meets requirements specified by ANSI S-3.22 1987. User controls and methods are similar to other products currently on the market. Sound processing for this instrument is also similar to devices presently marketed by Qualitone.
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