(69 days)
No
The description focuses on standard hearing aid technology, digital programming, and memory capacity, with no mention of AI or ML capabilities.
Yes
The device is described as a "hearing instrument" that "compensates for hearing losses from mild to severe" by amplifying sound pressure waves. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation:
The device is described as a hearing instrument that amplifies sound pressure waves to compensate for hearing losses. Its intended use is to transmit amplified sound to the external ear. This function is a treatment or compensation for a known condition (hearing loss), not a process of diagnosis (identifying a condition, its nature, or its cause).
No
The device description explicitly states it is an "air-conduction behind-the-ear hearing instrument with body-worn processor" and is powered by batteries, indicating it is a hardware device with potential software components, not a software-only 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 pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses." This describes a device that interacts with the physical environment (sound waves) and the body (external ear) to provide a therapeutic benefit (hearing compensation).
- Device Description: The description reinforces this by detailing an "air-conduction behind-the-ear hearing instrument."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a person's health status based on such analysis. IVDs are designed to diagnose, monitor, or screen for diseases or conditions by examining samples taken from the body.
This device falls under the category of a hearing aid, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
- This air-conduction behind-the-ear hearing instrument with body-worn processor 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 severe.
Product codes
Not Found
Device Description
- The device is powered by a standard hearing aid battery (type 13) and 2 standard alkaline type ● AAA batteries.
- . 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 Audallion® II Hearing System are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™.
- The ability to program digitally the fitting parameters of the hearing device is the same as in . the ReSound® BT4 Personal Hearing System™, as is the ability to change the characteristics of the sound processing and adjust the volume.
- The Audallion® II Hearing System has the ability to retain up to four programs in memory, . whereas the predicate device has the ability to retain two.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hearing aid dispenser
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 written in a large, bold, sans-serif font. The "R" has a decorative flourish. A registered trademark symbol is next to the "D". Below the logo, the words "HEARING HEALTH CARE" are written in a smaller, sans-serif font.
MAR 3 | 1997
Audallion® II Hearing System
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence for the Audallion® II Hearing System to the predicate device, the ReSound® BT4 Personal Hearing System™, 510(k) No. K964557, Nov. 27, 1996, is based on the following:
- This air-conduction behind-the-ear hearing instrument with body-worn processor 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 severe.
- The device is powered by a standard hearing aid battery (type 13) and 2 standard alkaline type ● AAA batteries.
- . 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 Audallion® II Hearing System are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™.
- The ability to program digitally the fitting parameters of the hearing device is the same as in . the ReSound® BT4 Personal Hearing System™, as is the ability to change the characteristics of the sound processing and adjust the volume.
- The Audallion® II Hearing System has the ability to retain up to four programs in memory, . whereas the predicate device has the ability to retain two.