(14 days)
K912665/A
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No
The summary describes a standard digital hearing aid with programmable parameters and remote control, but there is no mention of AI or ML capabilities. The description focuses on traditional hearing aid functions and comparisons to a predicate device with similar features.
Yes
The device is a hearing instrument designed to compensate for mild to severe hearing loss, which is a therapeutic function.
No
This device is described as a "hearing instrument" designed to "amplify sound pressure waves" and "compensate for hearing losses," which indicates it is a therapeutic or assistive device, not one used for diagnosis.
No
The device description explicitly states it is a "behind-the-ear hearing instrument" and is "powered by a standard hearing aid battery (type 13)," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description: The description clearly states that this is an air-conduction behind-the-ear hearing instrument designed to amplify sound pressure waves and transmit them to the external ear. It compensates for hearing loss.
- Intended Use: The intended use is to compensate for hearing losses, not to examine specimens from the human body.
- Mechanism of Action: The device works by amplifying sound and delivering it to the ear, not by analyzing biological samples.
Therefore, this device falls under the category of a hearing aid, which is a medical device but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- This air-conduction behind-the-ear hearing instrument, intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe.
Product codes
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Device Description
- This air-conduction behind-the-ear hearing instrument...
- The device is powered by a standard hearing aid battery (type 13).
- 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 to program digitally the fitting parameters of the hearing device is the same as in ● the ReSound® Personal Hearing System BT, as is the ability to change the characteristics of the sound processing and adjust the volume via an ultrasound remote control. The ReSound® BT4 Personal Hearing System™ and the predicate device have the ability to retain two programs in memory.
- The operation and functioning of the DAI option is identical to that offered by other hearing ● aid manufacturers.
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
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Key Metrics
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Predicate Device(s)
K912665/A
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
Image /page/0/Picture/0 description: The image shows the logo for ReSound Hearing Health Care. The word "ReSound" is in a large, bold, serif font, with a registered trademark symbol to the right of the "D". Below the word "ReSound" is the phrase "HEARING HEALTH CARE" in a smaller, sans-serif font.
NOV 27 1996
ReSound® BT4 Personal Hearing System™
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence for the ReSound® BT4 Personal Hearing System™ to the predicate device, the ReSound® Personal Hearing System BT (marketed as the BT2), 510(k) No. K912665/A, July 24, 1991, is based on the following:
- This air-conduction behind-the-ear hearing instrument, intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air, is designed to compensate for hearing losses from mild to severe.
- The device is powered by a standard hearing aid battery (type 13).
- 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 intended use, performance specifications, functions and operations of the ReSound® BT4 . Personal Hearing System™ are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® Personal Hearing System BT.
- The ability to program digitally the fitting parameters of the hearing device is the same as in ● the ReSound® Personal Hearing System BT, as is the ability to change the characteristics of the sound processing and adjust the volume via an ultrasound remote control. The ReSound® BT4 Personal Hearing System™ and the predicate device have the ability to retain two programs in memory.
- The operation and functioning of the DAI option is identical to that offered by other hearing ● aid manufacturers.