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The Jabra Enhance Plus self-fitting hearing aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

Device Description

The Jabra Enhance Plus is a wireless, self-fitting air-conduction hearing aid system. It incorporates microphones on the earbuds for audio input into the ear, and it can be controlled wirelessly via Bluetooth Low Energy using the mobile app, the Jabra Enhance, installed on a compatible iPhone, iOS 14 or later. Further control of the earbuds is possible via an on-device user control button on both the Left and Right earbud. In addition to hearing aid functionality for environmental listening, the Jabra Enhance Plus earbuds can be used for placing and receiving telephone calls and for streaming audio from a compatible, Bluetooth compliant mobile device that has been paired with the earbuds. The controls accessible through the Jabra Enhance mobile app and on the earbuds are used to configure parameters, settings, and listening modes of the earbuds. The earbuds integrate a rechargeable 3.7V/15mAh li-ion battery coin cell inside each earbud, and they are recharged by the on-the-go charging case that also serves as a carrying case. The mobile app is connected to the Internet Services that enable remote upgrades to the earbud firmware in support of continued enhancements.

AI/ML Overview

The provided document is a 510(k) Summary for the Jabra Enhance Plus self-fitting air-conduction hearing aid. It outlines the device's characteristics, comparison to a predicate device (Bose Hearing Aid), and the studies conducted to demonstrate its safety and effectiveness for substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state acceptance criteria in numerical targets for all aspects, but rather compares the Jabra Enhance Plus (Subject Device) to a predicate device (Bose Hearing Aid) and relevant standards. The "Discussion" column often acts as a statement of meeting implied criteria (e.g., "Same as predicate," "Comparable to predicate and suitable for the intended user"). Performance is reported against technical standards and clinical equivalence.

Evaluation Criterion / Characteristic	Acceptance Criteria (Implied/Standard)	Reported Device Performance (Jabra Enhance Plus)	Discussion (Meeting Acceptance)
Indications for Use	Same as predicate (amplify sound for individuals 18+ with perceived mild to moderate hearing impairment, self-adjusted, no pre-programming/hearing test, direct-to-consumer, no professional assistance)	Same as predicate	Met: "The Indications for Use are the same."
Intended Use	Same as predicate (amplify sound for individuals 18+ with perceived mild to moderate hearing impairment)	Same as predicate	Met: "The intended uses are the same."
Technological Characteristics
Housing	Biocompatibility and safety characteristics comparable to predicate.	In-ear earbuds (different from predicate's neckband)	Met: "difference in housing does not raise different questions of safety or effectiveness. Biological safety characteristics same as predicate device. Nonclinical data from biological safety testing and data from a clinical validation study support substantial equivalence."
Wireless communication	Wireless communication with handheld device via Bluetooth	Wireless communication with handheld device via Bluetooth	Met: "Same as predicate"
Wireless coexistence	Complies with AAMI TIR 69 (temporary loss of Bluetooth communication a negligible risk)	Uses 2.4GHz Classic Bluetooth and BLE; risk assessment determined temporary loss of Bluetooth communication from interfering RF signals is negligible.	Met: "Same as predicate"
Wireless user control functions via mobile app	Functionally similar to predicate. Fine-tuning options typical for mild-moderate hearing loss.	Volume Control (-12dB to +6dB), Listen Mode (Surround, adaptive, focus), Preferred filter (full, normal, clear)	Met: "Bose Hearing Aid allows for Left/Right balance control, however Left/Right balance is achieved through the self-fitting process in the subject device and as such, is inherent in the self-fitted device. The additional Bose Left/Right balance does not raise different questions of safety or effectiveness. Nonclinical data from a formative usability study and data a clinical validation study support substantial equivalence."
Bluetooth pairing, control, streaming	Verification with paired mobile device	Pairing, control, streaming verification with the paired mobile device.	Met: "Same as predicate"
Battery life	Rechargeable, providing ~10 hours of battery life	Rechargeable 3.7V/15mAh li-ion battery coin cells, 10 hours battery life (implied from discussion)	Met: "While battery capacity is different, both devices are rechargeable and allow for 10 hours of battery life on a full charge, and as such the difference in battery capacity does not raise different questions of safety or effectiveness."
Charging	Safe charging method not raising new questions of safety/effectiveness	Proprietary On-The-Go charging case via physical connection (Pogo pins), with internal 3.7V/129mAh li-ion battery for on-the-go charging, supports USB power.	Met: "Charging the subject device hearing aids in a portable charging case with or without connecting the charging case to a power supply via a USB cable does not raise different questions of safety or effectiveness. Non-clinical data from a formative usability study support substantial equivalence."
Microphones	Omnidirectional and directional modes, suitable for intended use.	Omnidirectional or directional modes (Surround, adaptive, focus). Supports adaptive directional mode.	Met: "The added automatic selection of directionality does not raise different questions of safety or effectiveness... Clinical data from peer-reviewed literature (Wu et al. Ear Hear. 2019) and a clinical validation study support substantial equivalence."
Device control	Comparable to predicate, not raising new safety/effectiveness questions.	On-Device user controls for volume, mute, mobile calls. Bluetooth pairing via removal from charging case.	Met: "The added call controls and different means of engaging BlueTooth pairing do not raise new questions for safety or effectiveness. Nonclinical data from a summative usability study and data from a clinical validation study support substantial equivalence."
Compression	Channels allowing for similar spectral tilt as predicate.	17 channel wide band dynamic range compression	Met: "The 5 additional channels... offer similar spectral tilt as predicate device. The 5 additional channels do not raise different questions of safety or effectiveness. Data from a clinical validation study support substantial equivalence."
Noise reduction	Proven effective, not raising new safety/effectiveness questions.	Steady-state noise reduction, impact noise control. No active noise reduction. (Different from predicate).	Met: "While differences in the implementation of noise cancellation exist, the methods developed by GN Hearing have proven effective in products already on the market, and therefore do not raise different questions of safety or effectiveness. Clinical data from peer-reviewed literature (Wu et al. Ear Hear. 2019) and a clinical validation study support substantial equivalence."
Feedback cancellation	Feedback canceller present	Feedback canceller	Met: "Same as Predicate"
Telephone calls	Placing and receiving telephone calls capability	Placing and receiving telephone calls	Met: "Same as Predicate"
Mobile App compatibility	Not raising different safety/effectiveness questions even with reduced compatibility.	iOS only (Predicate compatible with iOS & Android).	Met: "The lack of compatibility with handheld Android devices does not raise different questions of safety or effectiveness. Nonclinical data from a summative usability study and data from a clinical validation study support substantial equivalence."
Self-fitting method	Validated algorithm, not raising different safety/effectiveness questions.	NAL-NL2 fitting algorithm	Met: "NAL-NL2 is widely used by hearing care professionals... As such the difference in fitting does not raise different questions of safety or effectiveness. Data from a clinical validation study support substantial equivalence."
Remote Firmware update	Cybersecurity risks assessed and mitigated, not raising different safety/effectiveness questions.	Allows remote firmware update via app/cloud.	Met: "This feature does not raise different questions of safety or effectiveness. Nonclinical data documented in the cyber risk register support substantial equivalence."
Exposure to nonionizing radiation (IEC 62479:2010)	Sufficiently safe in terms of human exposure to nonionizing radiation.	Passes according to IEC 62479:2010.	Met: "Comparable to predicate. Uses same Bluetooth technology. Nonclinical data from verification testing in accordance with IEC 62478:2010 (human exposure to electromagnetic fields) support substantial equivalence."
Electroacoustic characteristics (ANSI/ASA S3.22-2014 & ANSI/CTA 2051:2017)	Comparable to predicate and suitable for intended user. Latency

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