(20 days)
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No
The description focuses on standard hearing aid technology, digital programming, and algorithms for fitting parameters, with no mention of AI or ML.
Yes
The device is described as a "hearing instrument intended to amplify sound pressure waves and transmit the signal to the external ear...to compensate for hearing losses." This function is a therapeutic intervention for hearing loss.
No.
The device is a hearing instrument intended to amplify and transmit sound to compensate for hearing loss, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "hearing instrument" powered by a battery and delivered completely assembled, indicating it is a physical 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 sound and transmit it to the external ear to compensate for hearing loss. This is a direct interaction with the patient's body (the ear) to improve a physical function (hearing).
- Device Description: The description details a hearing instrument that processes sound and delivers it to the ear. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens.
- Providing diagnostic information about a disease or condition based on sample analysis.
- Using reagents or other materials to perform tests on samples.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This hearing instrument does not fit that definition.
N/A
Intended Use / Indications for Use
- This air-conduction hearing instrument is intended to amplify sound pressure waves and ● transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderate.
Product codes
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Device Description
The device is powered by a standard hearing aid battery (type 10A). ● The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices.
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
external ear
Indicated Patient Age Range
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Intended User / Care Setting
hearing aid dispenser
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.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
OV 4 1996
ReSound® CC4 Personal Hearing System™
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence of the ReSound® CC4 Personal Hearing System™ to the ReSound® Personal Hearing System™ ED4-C (now known as the IC4), 510(k) No. K951067, May 12, 1995, is based on the following:
- This air-conduction hearing instrument is intended to amplify sound pressure waves and ● transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to moderate.
- The device is powered by a standard hearing aid battery (type 10A). ●
- The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices.
- The ability of the hearing aid dispenser to program digitally the fitting parameters of the . ReSound® CC4 hearing device is the same as in the ReSound® IC4.
- The ability to change the characteristics of the sound processing and to adjust the volume via an ● optional remote control is the same as that offered by the commercial device, the ReSound® IC4.
- The algorithm used by the ReSound® computerized fitting system to compute sets of fitting . parameters is similar to that used for the ReSound® IC4 with adjustments made for the acoustic differences between the IC4 and the ReSound® CC4.
- The performance specifications, functions and operations of the ReSound® CC4 Personal ● Hearing System™ is substantially equivalent to that described in the predicate device 510(k) Premarket Notification.