Who is the manufacturer of Jabra Enhance Plus?

GN Hearing A/S filed the 510(k) submission for Jabra Enhance Plus (K213424).

What is the FDA product code for Jabra Enhance Plus?

QDD. It is classified under 21 CFR 874.3325 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for Jabra Enhance Plus?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Jabra Enhance Plus?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Jabra Enhance Plus

K213424 · GN Hearing A/S · QDD · Jan 19, 2022 · Ear, Nose, Throat

Device Facts

Record ID	K213424
Device Name	Jabra Enhance Plus
Applicant	GN Hearing A/S
Product Code	QDD · Ear, Nose, Throat
Decision Date	Jan 19, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3325
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Wireless, self-fitting air-conduction hearing aid system; consists of two in-ear earbuds and a portable charging case. Inputs audio via earbud microphones; processes sound using 17-channel wide-band dynamic range compression, feedback cancellation, and noise reduction. Controlled via Jabra Enhance mobile app (iOS 14+) or on-device buttons for volume, listening modes (surround, adaptive, focus), and spectral tilt. Used by patients with mild-to-moderate hearing loss in home/everyday environments. Enables telephone calls and audio streaming via Bluetooth Low Energy. Firmware updates delivered via cloud-connected mobile app. Benefits include improved speech communication and listening in everyday situations without professional fitting.

Clinical Evidence

Clinical validation study (n=38) compared self-fitting (SELF-FIT) to professional fitting (PRO-FIT). Primary endpoint: REAR results showed reliability of self-fitting. Secondary endpoint: QuickSIN scores showed statistical equivalence (within ±1.5 dB) across conditions. Field trial (n=37) showed APHAB-global scores for SELF-FIT were statistically non-inferior to PRO-FIT. No adverse events reported.

Technological Characteristics

Wireless air-conduction hearing aid; 3.7V/15mAh Li-ion battery per earbud. Connectivity: Bluetooth Low Energy (2.4GHz). Electroacoustic performance per ANSI S3.22-2014 and ANSI/CTA 2051:2017. Biocompatibility per ISO 10993-1. Software: Moderate level of concern. Firmware updateable via cloud.

Indications for Use

Indicated for individuals 18+ with perceived mild to moderate hearing impairment. Adjusted by user; no pre-programming or hearing test required. Intended for direct-to-consumer sale and use without professional assistance.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the self-fitting air-conduction hearing aid is subject to the following special controls: - 1. Clinical data must evaluate the effectiveness of the self-fitting strategy. - 2. Electroacoustic parameters, including maximum output limits, distortion levels, selfgenerated 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: - (A) Performance testing must validate safety of exposure to non-ionizing radiation; - (B)Performance data must validate wireless technology functions; and - (C) Labeling must specify instructions, warnings, and information relating to wireless technology and human exposure to non-ionizing radiation. - 6. Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use. - 7. Patient labeling must include the following: - (A)Information on how a patient can self-identify as a candidate for the device; - (B) Information about when to seek professional help; - (C) A warning about using hearing protection in loud environments; - (D) A warning about staying alert to sounds around the user of the device; - (E) Technical information about the device, including information about electromagnetic compatibility; and - (F) Information on how to correctly use and maintain the device.

*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.

Predicate Devices

Bose Hearing Aid (DEN180026)

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Submission Summary (Full Text)

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # 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.…