(90 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard hearing aid technology and user-controlled adjustments via a mobile app.
Yes
The device is intended to amplify sound for individuals with perceived mild to moderate hearing impairment, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
Explanation: The device is described as a "self-fitting hearing aid" intended to "amplify sound" for individuals with perceived hearing impairment. It does not perform a diagnostic function to identify or characterize a disease or condition, but rather provides a treatment (sound amplification) based on the user's perceived needs. The "No pre-programming or hearing test is necessary" statement further supports that it's not a diagnostic tool.
No
The device description clearly states it is a "wireless, self-fitting air-conduction hearing aid system" and includes physical components like microphones, earbuds, a rechargeable battery, and a charging case. While it utilizes a mobile app for control, it is not solely software.
Based on the provided information, the Jabra Enhance Plus self-fitting hearing aid is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment." This describes a device that modifies sound for therapeutic purposes (addressing hearing loss), not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the device's function as a hearing aid, including microphones, wireless control, audio streaming, and power. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device interacts with the user's auditory system directly by amplifying sound.
- Clinical Study Focus: The clinical studies described evaluate the device's performance in amplifying sound and improving hearing, not its ability to diagnose or monitor a condition through specimen analysis.
In summary, the Jabra Enhance Plus is a medical device designed to address hearing impairment through sound amplification, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QDD, QUH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Direct-to-consumer sale and use without the assistance of a hearing care professional.
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
A clinical validation study was conducted across two geographically disparate U.S. clinical audiology sites. Subjects, aged 28 to 73 years (N=38), ½ male and ½ female, were fitted bilaterally with prototype Jabra Enhance Plus hearing aids. About 66% (25/38) of the subjects had never worn hearing aids before. Study criterion was mild to moderate bilateral sensorineural hearing loss (from 250 through 8000 Hz with at least one threshold >20 dB HL and thresholds at 500, 1000, 2000 and 4000 Hz
§ 874.3325 Self-fitting air-conduction hearing aid.
(a)
Identification. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. A self-fitting air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must evaluate the effectiveness of the self-fitting strategy.
(2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) If the device incorporates wireless technology:
(i) Performance testing must validate safety of exposure to non-ionizing radiation; and
(ii) Performance data must validate wireless technology functions.
(6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.
0
On August 17, 2022, FDA issued a final rule establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. See here: https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-overthe-counter-hearing-aids. The rule is effective October 17, 2022.
As part of this final rule, FDA amended the existing classification regulation for self-fitting air-conduction hearing aids, 21 CFR 874.3325, to identify these as hearing aids subject to the requirements in 21 CFR 800.30 or 21 CFR 801.422.
While the device submitted and cleared through K213424 may serve as a valid predicate device for a new self-fitting air-conduction hearing aid, please refer to the aforementioned final rule for current regulatory requirements for this device type.
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". The logo is simple and professional, and it is easily recognizable.
July 5, 2023
GN Hearing A/S Lars Hagander Head of Regulatory Governance & Intelligence Lautrupbjerg 7 Ballerup, DK-2750 Denmark
Re: K213424 Trade/Device Name: Jabra Enhance Plus Regulation Number: 21 CFR 874.3325 Regulation Name: Self-fitting air-conduction hearing aid Regulatory Class: Class II Product Code: QDD, QUH
Dear Lars Hagander:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 19, 2022. Specifically, FDA is updating this SE Letter to add the product code QUH. This change corresponds to the establishment of a regulatory category for over-the-counter hearing aids and related amendments to update the regulatory framework for hearing aids, as detailed in the final rule published on August 17, 2022 (see here for more information: https://www.federalregister.gov/documents/2022/08/17/2022-17230/medicaldevices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids). This product code change is intended to better categorize your device consistent with the final rule. This an administrative change only and there is no impact on your 510(k) clearance.
For questions regarding this letter please contact Shu-Chen Peng, Ph.D., OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Devices, (301) 796-6481, shu-chen.peng@fda.hhs.gov.
Sincerely.
Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Image /page/2/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name in blue text.
January 19, 2022
GN Hearing A/S Lars Hagander Head of Regulatory Governance & Intelligence Lautrupbjerg 7 Ballerup, DK-2750 Denmark
Re: K213424
Trade/Device Name: Jabra Enhance Plus Regulation Number: 21 CFR 874.3325874.3325 Regulation Name: Self-fitting air-conduction hearing aid Regulatory Class: Class II Product Code: QDD Dated: October 19, 2021 Received: October 21, 2021
Dear Lars Hagander:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
3
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K213424
Device Name Jabra Enhance Plus
Indications for Use (Describe)
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's hearing needs. No preprogramming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
Restricted Device (per 21 CFR 801.420 and 21 CFR 801.421).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K213424
Applicant Name and Address
| Name | GN Hearing A/S |
|---|---|
| Address | Lautrupbjerg 7 |
| DK-2750 Ballerup | |
| Denmark | |
| Tel: +45 4575 1111 | |
| Fax: +45 4575 1119 | |
| Official Contact | Lars Hagander |
| Senior Director of Regulatory, Governance & Intelligence, GN | |
| Hearing | |
| Tel: +45 4575 1111 | |
| E-mail: lhagander@gnresound.com |
January 19, 2022 Summary Preparation Date
Device name and Classification
| Trade Name | Jabra Enhance™ Plus |
|---|---|
| Common/Usual Name | Self-fitting air-conduction hearing aid |
| Classification Name | Self-fitting air-conduction hearing aid |
| Regulation Number | 21 CFR 874.3325 |
| Product Code | QDD |
| Classification | Class II |
| Panel | Ear, Nose and Throat Devices |
| Predicate Device | Bose® Hearing Aid (DEN180026) |
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
6
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.
Figure 1 below illustrates the supported interactions and interfaces between the earbuds, the mobile app, the charging case, and the internet service.
Image /page/6/Figure/2 description: The image shows a diagram of the Jabra Enhance mobile app and its connection to other devices. The app connects to the internet services and earbuds via Bluetooth Low Energy. The earbuds connect to the charger via Bluetooth Low Energy and Galvanic connection, and they also use GN Proprietary Protocol.
Figure 1. Jabra Enhance Plus - System interactions and interfaces between components and the internet.
Intended Use
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.
Indications for Use
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
7
device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.
Self-Selection Labeling
Self-Selection labeling is included in the Jabra Enhance Plus IFU to mitigate the risk of improper self-selection. In summary, it addresses:
- Identifying situations in which the Jabra Enhance Plus may help you hear better. ●
- Identifying situations in which the Jabra Enhance Plus may not be right for the user. .
- Identifying criteria that indicate the user should see a hearing professional. ●
- . Informing the user that the Jabra Enhance Plus will not restore normal hearing.
- Informing the user that it is good health practice to have hearing loss evaluated by an . appropriate healthcare professional.
Special Controls
The Jabra Enhance Plus conforms to the special controls stated in 21 CFR 874.3325. The Jabra Enhance Plus satisfied these requirements through:
- Clinical data
- Non-clinical performance testing ●
- Human factors validation / Usability testing ●
- . Labeling
Comparison of Technological Characteristics
The key similarities and differences between the Bose® Hearing Aid (predicate device) and the Jabra Enhance Plus (subject device) with respect to the technological characteristics are summarized in Table 1 below.
8
| Evaluation
Criterion | Characteristic | Jabra Enhance Plus
(Subject Device) | Bose Hearing Aid
(Predicate Device) | Discussion |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for Use | 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. | The Bose 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. | The Indications for Use are the
same. |
| | Intended Use | 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. | The Bose Hearing Aid is intended
to amplify sound for individuals
18 years of age or older with
perceived mild to moderate
hearing impairment. | The intended uses are the same. |
| Technological Characteristics | | | | |
| | Technology | Wireless, self-fitting air conduction
hearing aid | Wireless, self-fitting air conduction
hearing aid | Same as predicate |
| | Housing | In-ear hearing aid housing. Separate
left and right ear units (earbuds)
with a user control push button on
each unit.
Image: Two earbuds | Hearing aid neckband housing that
connects to both the left and right
ear units with user controls on right
earbud wire.
Image: A neckband with earbuds | Although the subject device
hearing aid housing is wireless
and in-ear instead of a neckband
with wired earbuds, the 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 | Same as predicate |
| AAMI TIR 69: 2017 | Wireless
coexistence | The GN Hearing Aid uses standard
2.4GHz Classic Bluetooth and
Bluetooth Low Energy (BLE)
standards to communicate between
the hearing aid and the user's
Bluetooth enabled device. From the
risk assessment, the temporary loss
of Bluetooth communication from
interfering RF signals is
appropriately considered a
negligible risk and according to
AAMI TIR 69, wireless coexistence
testing is not required. Note that the
interruption of device control from
the App would be similar to when
the user is separated from their | The Bose BMD-001 Hearing Aid
uses standard 2.4GHz Classic
Bluetooth and Bluetooth Low
Energy (BLE) standards to
communicate between the hearing
aid and the user's Bluetooth
enabled device. From the risk
assessment, the temporary loss of
Bluetooth communication from
interfering RF signals is
appropriately considered a
negligible risk and according to
AAMI TIR 69, wireless coexistence
testing is not required. Note that the
interruption of device control from
the App would be similar to when | Same as predicate |
| Evaluation
Criterion | Characteristic | Jabra Enhance Plus
(Subject Device) | Bose Hearing Aid
(Predicate Device) | Discussion |
| | | Bluetooth enabled device. | the user is separated from their
Bluetooth enabled device. | |
| | Wireless user
control functions
via mobile app | Volume Control (-12dB to +6dB)
Listen Mode (Surround, adaptive,
focus)
Preferred filter (full, normal, clear) | Volume control
Modes (everywhere, front, focused)
Tone correction
Left/Right balance | 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. |
| | Demonstrate that
hearing Aid device
initiates Bluetooth
pairing, and
Bluetooth control
and streaming
functionality | Pairing, control, streaming
verification with the paired mobile
device. | Pairing, control, streaming
verification with the paired mobile
device. | Same as predicate |
| | Battery | Hearing Aid with a single cell
rechargeable 3.7V/15mAh li-ion
battery coin cells inside each
earbud. | Hearing Aid with a single cell
rechargeable 3.7V/270mAh li-
ionbattery inside neckband. | 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.
Nonclinical data from battery
safety testing and data from a |
| Evaluation
Criterion | Characteristic | Jabra Enhance Plus
(Subject Device) | Bose Hearing Aid
(Predicate Device) | Discussion |
| | Charging | Jabra Enhance Plus hearing aids,
are charged in a proprietary On-
The-Go charging case via a
physical connection through Pogo
contact pins in the charging case.
The charging case itself contains a
single cell 3.7V/129mAh li-ion
battery that allows the user to
charge the earbuds on-the-go
without the need for being
connected to a power outlet.
The charging case supports both
self-powered operation and/or
being powered by a standard USB
cable connected to a power supply.
When connected to a USB power
supply, the internal battery is
recharged, allowing for future on-
the-go charge of the earbuds. | Hearing aid is charged via USB
cable connected to a power supply
and to the neckband where the
rechargeable battery source is
located. | clinical validation study support
substantial equivalence.
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 | Microphones in earbuds may,
during use, be configured by the
user in omnidirectional or
directional modes,
Surround, adaptive, focus. | Microphones in earbud may, during
use, be configured by the user in
omnidirectional or directional
modes, everywhere, front, focused. | The subject device as well as the
predicate device allow for
omnidirectional and speech focus
options.
The subject device supports an
adaptive directional mode that
allows the earbuds to determine
the most suitable directionality for
the microphones for the given
environment.
The added automatic selection of
directionality does not raise
different questions of safety or
effectiveness. |
| Evaluation
Criterion | Characteristic | Jabra Enhance Plus
(Subject Device) | Bose Hearing Aid
(Predicate Device) | Discussion |
| | | | | Directional Microphone options
were made available to the study
participants during the field trial
as also was done for the predicate
device.
Slight differences in the
directional microphone
parameters between subject and
predicate device do not impact the
study population.
Clinical data from peer-reviewed
literature (Wu et al. Ear Hear.
2019) and a clinical validation
study support substantial
equivalence. |
| | Device control | On-Device user controls:
- Volume up/down
microphone - Volume up/down
streaming - Mute
- Answer mobile call
- End or reject mobile call | On-Device user controls:
- Volume up/down
microphone - Volume up/down
streaming - Power on/off button
- BlueTooth pairing button | Sound adjustment features on
predicate and subject devices are
identical.
Jabra Enhance Plus further
supports mobile phone call
controls.
Bluetooth pairing mode is entered
when the earbuds are removed
from the charging case.
The added call controls and
different means of engaging
BlueTooth pairing do not raise
new questions for safety or
effectiveness. |
| Evaluation
Criterion | Characteristic | Jabra Enhance Plus
(Subject Device) | Bose Hearing Aid
(Predicate Device) | Discussion |
| | | | | Nonclinical data from a
summative usability study and
data from a clinical validation
study support substantial
equivalence. |
| | Compression | 17 channel wide band dynamic
range compression | 12 channel wide band dynamic
range compression | The 5 additional channels on the
subject device, as they are lumped
into base, mid and treble and 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 | Steady-state noise reduction, where
background noise is filtered out
from sound occurring at the
microphones.
Impact noise control.
No support for active
noise reduction. | Active noise reduction.
Impact noise control. | Subject device does not support
adaptive noise cancellation like
predicate device, however the
subject device incorporates the
same algorithms already proven
effective in products released to
the market by GN Hearing, like
Primary DI Number
05708296195077, exempt from
premarket notification.
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 |
| Evaluation
Criterion | Characteristic | Jabra Enhance Plus
(Subject Device) | Bose Hearing Aid
(Predicate Device) | Discussion |
| | | | | Noise reduction features were
available to the study participants
during the field trial as also was
done for the predicate device.
Slight differences exist in the
noise reduction parameters
between subject and predicate |
| | | | | device but do not impact the study
population.
Clinical data from peer-reviewed
literature (Wu et al. Ear Hear.
2019) and a clinical validation
study support substantial
equivalence. |
| | Feedback
cancellation | Feedback canceller. | Feedback canceller. | Same as Predicate |
| | Telephone calls | Placing and receiving telephone
calls. | Placing and receiving telephone
calls. | Same as Predicate |
| | Mobile App | Same as Predicate with respect to
iOS
Not compatible with Android. | Mobile application, on handheld
device (iOS or Android) used to
configure parameters, settings, and
listening modes. | 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 | Apply personalized gain settings
based on user input and Fine-
Tuning.
Utilizes the validated NAL-
NL2fitting algorithm. | Loudness and Fine-Tuning.
Utilizes a proprietary fitting
algorithm. | Subject device uses a validated
NAL-NL2 fitting algorithm
instead of a proprietary algorithm
as used by the predicate device.
NAL-NL2 is widely used by
hearing care professionals to fit
persons with mild to moderate
hearing loss. |
| Evaluation
Criterion | Characteristic | Jabra Enhance Plus
(Subject Device) | Bose Hearing Aid
(Predicate Device) | Discussion |
| | | | | Legally marketed hearing aids
exempt from 510(k) also embed
the NAL-NL2 fitting algorithm,
but these exempt hearing aids are
fitted 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 | The Jabra Enhance app allows for
remote firmware update of the
earbuds via the Cloud. | Unknown | Remote firmware update allows
GN to maintain and improve the
Jabra Enhance Plus and
continuously strengthen
cybersecurity as new mobile
operating systems are released.
Allowing for Remote Firmware
Updates is assessed as part of the
cybersecurity risk process, and
risk mitigations are developed per
the device hazard analysis, and
cybersecurity associated with the
RFU internet service.
Patient risks associated with
RFUs are understood, mitigated
and the subject device is
considered safe. This feature does
not raise different questions of
safety or effectiveness.
Nonclinical data documented in
the cyber risk register support |
| Evaluation
Criterion | Characteristic | Jabra Enhance Plus
(Subject Device) | Bose Hearing Aid
(Predicate Device) | Discussion |
| Exposure to nonionizing radiation | | | | substantial equivalence. |
| Special control 5i | Exposure to
nonionizing
radiation | Passes according to:
IEC 62479:2010
And deemed sufficiently safe in
terms of human exposure to
nonionizing radiation exposure. | The Bose Hearing Aid contains a
Bluetooth radio transmitter
operating in the ISM band (2.400 to
2.4835 GHz) at less than 10 mW
EIRP. The output power level at
these operating frequencies of the
Bose Hearing Aid was deemed
sufficiently safe in terms of human
exposure to nonionizing
radiationfor the intended use. | 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 performance | | | | |
| Special control 2
ANSI/CTA 2051-
2017 and underlying
ANSI S3.22-2014 | Electroacoustic
characteristics | Frequency range: 100-8700 Hz.
Maximum output (90 dB SPL
input): 110 dB SPL.
Equivalent noise input level: 26dB
HFA Full-On-Gain (50 dB SPL
input): 25 dB
Latency: 20 dB HL and thresholds at 500. 1000. 2000 and 4000 Hz