(202 days)
BHA100 Series Braun® Clear™ Hearing Aid - K212609
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the hearing assessment system as using a "unique programming formula designed for and used globally by hearing aid manufacturers," which is a standard algorithmic approach, not necessarily AI/ML.
Yes
The device is described as a "Hearing Aid" intended to "amplify sound for individuals... with perceived mild to moderate hearing impairment," which directly addresses a health condition (hearing impairment) through sound amplification, a therapeutic function.
Yes
The device is described as having "Ear ID, an innovative hearing assessment system that uses the NAL-NL2 unique programming formula designed for and used globally by hearing aid manufacturers. This hearing profile/personalization system in the IQbuds 2 PRO Hearing Aid assesses the individual's hearing levels across a frequency spectrum to customize the device's amplification specific to their hearing needs." This assessment of hearing levels is a diagnostic function, even though no pre-programming or hearing test is strictly necessary from an external source.
No
The device description explicitly states that the device consists of "the hearing aids with Ear Tips, Charge Case, Nuheara software, the Nuheara app, and accessories supplied in the carton." This indicates the presence of physical hardware components (hearing aids, charge case, ear tips) in addition to the software.
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 for individuals with perceived hearing impairment. This is a therapeutic and assistive function, not a diagnostic one.
- Device Description: The description focuses on the device's function as a hearing aid, including sound amplification, personalization based on hearing levels, and features like phone calls and audio streaming. It does not describe any function related to diagnosing a disease or condition from a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing a diagnosis based on such analysis. The "Ear ID" system is described as a hearing assessment system to customize amplification, not a diagnostic test for a medical condition.
- Regulatory Classification: The device is described as a "self-fitting wireless air conduction hearing aid (§ 874.3325)". This is a classification for hearing aids, not IVDs.
- Performance Studies: The performance studies focus on usability and clinical effectiveness in terms of sound amplification and user perception of hearing improvement, not on diagnostic accuracy (like sensitivity, specificity, etc., which are key metrics for IVDs).
In summary, the IQbuds 2 PRO Hearing Aids are designed to help individuals with hearing impairment hear better, which is a therapeutic and assistive function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The IQbuds 2 PRO Hearing Aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for over the counter sale and use without the assistance of a hearing care professional.
Product codes
OUH
Device Description
The Nuheara IQbuds 2 PRO Hearing Aid (Model NU320) is a self-fitting wireless air conduction hearing aid (§ 874.3325) consisting of the hearing aids with Ear Tips. Charge Case, Nuheara software, the Nuheara app, and accessories supplied in the carton. The device is indicated for over-the-counter sale.
The hearing aids are designed to be worn in both ears simultaneously with the appropriate size Ear Tips fitted to the sound port of the aid. The device has Ear ID, an innovative hearing assessment system that uses the NAL-NL2 unique programming formula designed for and used globally by hearing aid manufacturers. This hearing profile/personalization system in the IQbuds 2 PRO Hearing Aid assesses the individual's hearing levels across a frequency spectrum to customize the device's amplification specific to their hearing needs. In addition to hearing aid functionality for environmental and directive listening (using the microphones on the aids); the hearing aids can be used for making and receiving phone calls and for streaming audio from a Bluetooth®-compliant mobile device that has been paired with the Nuheara Hearing Aids.
The hearing aids are powered using 3.7V Li-lon coin cell batteries and the Charge Case powered using a Li-Ion Polymer battery. They can be recharged 'on the go' using the Charge Case, which can fully recharge the hearing aid battery three times before the Charge Case requires recharging. The Charge Case also serves as a helpful carrying case to enable mobile charging and protect the hearing aids while not in use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
user / over the counter 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
Not Found
Summary of Performance Studies
Usability Testing
Eighteen adults (18 yrs. and older) with a perceived mild to moderate hearing loss hearing loss were enrolled after passing screening of inclusion/exclusion criteria. Task driven Formative Evaluations followed by an inclusive Evaluation were conducted in a one-on-one quiet, comfortable room fit with two chairs and a table on which the participants could handle the device and a smartphone. Informed Consent was obtained for each participant before enrollment and all sessions were video-taped.
Overall, the human factors study demonstrated that the usability of the Nuheara hearing aid was analyzed, verified, and validated for its intended use, intended use environment and the implemented mitigations for user training and device labeling are adequate.
Clinical Performance
Study Type: Prospective investigation of clinical effectiveness.
Sample Size: 43 adults, mean age of 50.
Key Results:
- Quantitatively comparing target gain from the audiologist determined REM using standard audiologic practice (NAL-NL2) against the participant completed self-fit using the Nuheara Ear ID feature.
- REIG calculated deviations measures and corresponding 95% confidence intervals, based on the t-score method. The figure shows that REIG lies with ± 5 dB from NAL-NL2 target for frequencies below 3.5 kHz.
- Assessing perceptual measures of device effectiveness by utilizing the well characterized and validated APHAB and SSQ-12 self-reported questionnaires and EMA for real-time self-reporting of user listening experience while aided.
- The APHAB results indicated that the Nuheara Self-Fit aided condition improved the mean scores for ease of communication in noise by 17.8 points; in quiet by 7.4 points; and in reverberation - 8.2 points, out of a total score of 100. The global improvement was 11 points better when aided with the IQbuds 2 PRO Self-Fit. The Unaided to Aided difference in the scores were well within the published 5-30 (%) percentile norms for the APHAB (Cox and Alexander, 1995).
- SSQ results (Speech, Spatial, Qualities) for Nuheara were comparable to the Valente study which used NAL-NL2 fit (Speech: Nuheara 7 vs Valente 6.8; Spatial: Nuheara 7.1 vs Valente 7.5; Qualities: Nuheara 7.2 vs Valente 7.9).
- Speech in Noise: Participants scored 56% recall when unaided or aided without directional microphone, with performance increasing to 86% when directionality was employed.
Key Metrics
APHAB (Unaided vs Aided Mean Scores):
- EC (Ease of Communication): Unaided 22.4, Aided 14.3
- BN (Background Noise): Unaided 45.1, Aided 28.3
- RV (Reverberation): Unaided 31.8, Aided 23.6
- AV (Aversiveness): Unaided 41.9, Aided 41.2
- Global Score: Unaided 33.1, Aided 22.1
SSQ (Nuheara vs Valente):
- Speech: Nuheara 7, Valente 6.8
- Spatial: Nuheara 7.1, Valente 7.5
- Qualities: Nuheara 7.2, Valente 7.9
Speech in Noise: 56% recall when unaided or aided without directional microphone, 86% recall when directionality was employed.
Predicate Device(s)
Bose Hearing Aid - DEN180026
Reference Device(s)
BHA100 Series Braun® Clear™ Hearing Aid - K212609
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 30, 2022
Nuheara Limited % Deborah Arthur Regulatory Consultant DArthurConsulting 4830 Randolph Rd., Unit 3302 Charlotte, North Carolina 28211
Re: K221064
Trade/Device Name: Nuheara IQbuds 2 PRO Hearing Aid Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: OUH Dated: March 31, 2022 Received: April 11, 2022
Dear Deborah Arthur:
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/cfpmn/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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (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-device-advice-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,
Srinivas Nandkumar, Ph.D. 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
Enclosure
2
Indications for Use
510(k) Number (if known) K221064
Device Name Nuheara IQbuds 2 PRO Hearing Aid
Indications for Use (Describe)
The IQbuds 2 PRO Hearing Aids are intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for over the counter sale and use without the assistance of a hearing care professional.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized sound wave graphic above the word "NUHEARA" in a bold, sans-serif font. The sound wave graphic is composed of vertical bars of varying heights, with the central bars forming a stylized "N". The logo is in black and white.
510(k) Premarket Notification K221064
1
510(k) Summary - Nuheara Limited
1. SUBMITTER
Nuheara Limited 13555 S.E. 36th St. Ste. 100 Bellevue, WA 98006 U.S.A.
Contact Person: John Luna
Date Prepared: October 25, 2022
2. DEVICE [PER 807.92(a)(2)]
Name of Device: Nuheara IQbuds™ 2 PRO Hearing Aid - K221064 Classification Name: Self-fitting Air Conduction Hearing Aid Common Name: Self-fitting Hearing Aid Regulation: 21 CFR §874.3325 Requlatory Class: II Product Code: QUH
3. PREDICATE DEVICE [PER 807.92(a)(3)]
Predicate: Bose Hearing Aid - DEN180026 Reference: BHA100 Series Braun® Clear™ Hearing Aid - K212609
4. DEVICE DESCRIPTION [PER 807.92(a)(4)]
The Nuheara IQbuds 2 PRO Hearing Aid (Model NU320) is a self-fitting wireless air conduction hearing aid (§ 874.3325) consisting of the hearing aids with Ear Tips. Charge Case, Nuheara software, the Nuheara app, and accessories supplied in the carton. The device is indicated for over-the-counter sale.
The hearing aids are designed to be worn in both ears simultaneously with the appropriate size Ear Tips fitted to the sound port of the aid. The device has Ear ID, an innovative hearing assessment system that uses the NAL-NL2 unique programming formula designed for and used globally by hearing aid manufacturers. This hearing profile/personalization system in the IQbuds 2 PRO Hearing Aid assesses the individual's hearing levels across a frequency spectrum to customize the device's amplification specific to their hearing needs. In addition to hearing aid functionality for environmental and directive listening (using the microphones on the aids); the hearing aids can be used for making and receiving phone calls and for streaming audio from a Bluetooth®-compliant mobile device that has been paired with the Nuheara Hearing Aids.
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Image /page/5/Picture/0 description: The image is a logo for Nuheara. The logo consists of the word "NUHEARA" in bold, sans-serif font. Above the word is a stylized "N" formed by three vertical bars of varying heights. The logo is simple and modern, and the black and white color scheme gives it a clean and professional look.
510(k) Premarket Notification K221064
The hearing aids are powered using 3.7V Li-lon coin cell batteries and the Charge Case powered using a Li-Ion Polymer battery. They can be recharged 'on the go' using the Charge Case, which can fully recharge the hearing aid battery three times before the Charge Case requires recharging. The Charge Case also serves as a helpful carrying case to enable mobile charging and protect the hearing aids while not in use.
5. Intended Use
The Nuheara IQbuds 2 PRO self-fitting wireless air conduction hearing aids are intended to amplify sound for individuals with perceived mild to moderate hearing impairment.
6. Indications for Use
The Nuheara IQbuds 2 PRO self-fitting hearing aids are intended to amplify sound for individuals 18 years and older with perceived mild to moderate hearing impairment. They are adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for over the-counter sale and use without the assistance of a hearing care professional.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
The intended use and technological characteristics, e.g., features, parameter settings etc. are substantially equivalent to the predicate device (Bose) cited above. Table 1 summarizes the characteristics of the Nuheara IQbuds 2 PRO Hearing Aids in comparison to the predicate, the Bose Hearing Aid (DEN180026) and, as applicable, the reference device (BHA100 Series Braun® Clear™ Hearing Aid - K212609). The BHA100 device serves a reference device as the self-fitting strategy (i.e., self-administered hearing test and subsequently applied prescription) is similar to the subject device.
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Image /page/6/Picture/0 description: The image is a logo for Nuheara. The logo consists of the word "NUHEARA" in all caps, with a stylized "N" above it. The "N" is made up of three vertical bars of varying widths, with the middle bar being the thickest.
510(k) Premarket Notification
K221064
Table 1. Summary of Technological Characteristics
| Subject | Predicate | Reference | ||
|---|---|---|---|---|
| Device Trade | ||||
| name | Nuheara IQbuds™ 2 PRO | Bose Hearing Aid | BHA100 Series Braun® | |
| Clear™ Hearing Aid | Discussion of Differences | |||
| 510k Number | K221064 | DEN180026 | K212609 | |
| Product code | QUH | QDD | QDD | The over-the-counter version of the |
| self-fitting hearing aid has an updated | ||||
| product code to differentiate it from the | ||||
| DTC version (QDD). The only | ||||
| difference is the updated labeling as | ||||
| required by the enactment of the OTC | ||||
| Hearing Aid Final Rule on October 17. |
-
|
| Regulation
number | 21 CFR 874.3325 | 21 CFR 874.3325 | 21 CFR 874.3325 | Same as predicates |
| Regulation name | Self-fitting air conduction hearing
aid | Self-fitting air conduction
hearing aid | Self-fitting air conduction
hearing aid | Same as predicates |
| Intended Use | The IQbuds 2 PRO Hearing Aids is
intended to amplify sound for
individuals with perceived mild to
moderate hearing impairment. | The Bose Hearing Aid is
intended to amplify sound
for individuals with
perceived mild to
moderate hearing
impairment. | The BHA100 Series Braun®
Clear™ Hearing Aid is
intended to amplify sound for
individuals with perceived
mild to moderate hearing
impairment. | Same as predicates |
| | Indications for Use | | | |
| Indications for Use | The IQbuds 2 PRO Hearing Aids
are intended to amplify sound
for individuals 18 years of age
or older with perceived mild to
moderate hearing impairment.
They are adjusted by the user to
meet the user's hearing needs.
No pre-programming or hearing
test is necessary. The device is
intended for over-the-counter
sale and use without the
assistance of a hearing care
professional. | The Bose Hearing Aids are
intended to amplify sound
for individuals 18 years of
age or older with perceived
mild to moderate hearing
impairment. They are
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 BHAI00 Series
Braun® Clear™ Hearing
Aid is a self-fitting, air
conduction hearing aid,
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.
The device is intended
for direct-to-consumer
sale and use without the
assistance of a hearing
health care professional. | Same as predicate and reference |
| Technology | Rechargeable batteries
Lithium-ion polymer | Rechargeable battery
Lithium- ion polymer | | Subject device battery is
recharged in a 'Charge Case' that
stores and charges the battery at
the same time. While the predicate
recharges by use of an AC plug
adapter and connector into hearing
aid neckband to recharge. Neither
hearing aid can be used while
charging.
The difference in recharging
process does not introduce new
issues of safety as both devices
meet same battery standards |
| | Subject | Predicate | | |
| Device Trade
name | Nuheara IQbuds™ 2 PRO | Bose Hearing Aid | BHA100 Series Braun®
Clear™ Hearing Aid | Discussion of Differences |
| Housing | In-the-ear hearing aid
housing. Separate left and
right ear units (earbuds) with
a separate Ear Tip for each
unit.
On device, 'Tap Touch'
control to streaming audio
and use with phone (via
Bluetooth) | Hearing aid neckband housing
that connects to both the left and
right ear units with user controls
on right earbud wire.
Image: Bose Hearing Aid | | Although the subject
device hearing aid
housing is wireless and
in- the ear instead of a
neckband with wired
earbuds, the difference in
housing does not
raise different questions of
safety or effectiveness. |
| Input signal
compression | Wide dynamic range
compression | Wide dynamic range
compression | | Same as predicate |
| Microphones | Microphones in the earbud,
can be configured by the user
during use; via the Nuheara
app. To configure the
microphones to switch
between omni-directional and
directional sound, in the
Nuheara app you can toggle
the FOCUS feature ON / OFF. | Microphones in earbud may,
during use, be configured by the
user in omni-directional or
directional modes | | The subject device, as
well as the predicate,
allow for omni-directional
and speech focus
options. |
| Battery Life | Per CTA 2051 (4.1-4.17)
Battery life of up to 8 hrs | Per CTA 2051 (4.1-4.7)
Battery life of 10 hrs | Subject device has a
'portable' Charge Case for
charging the hearing aids a
any time or place should
there be a need for extended
use. | |
| | | | The battery life is similar to
that of the predicate.
However, the subject device
offers the advantage of 'on
the go' charging.
The battery life or the 'on the
go' charging does not raise
any new issues of safety and
effectiveness. | |
| Noise Reduction | Hybrid Active Noise
Cancellation | Active Noise Reduction (ANR) | The subject device
performs in a similar
manner to predicate and
does not raise different
issues of | |
| | Subject | Predicate | Reference | |
| Device Trade
name | Nuheara IQbuds™ 2 PRO | Bose Hearing Aid | BHA100 Series Braun®
Clear™ Hearing Aid | Discussion of Differences |
| | | | | effectiveness |
| Self-fitting method | Subject device uses a
proprietary Ear ID, a
validated NAL-NL2 fitting
algorithm, | Loudness and Fine-tuning
app-based Controllers.
Utilizes a proprietary fitting
algorithm. | Braun ClearCheck
Hearing Test is a feature
of the BHA100 Braun
Clear hearing aid. This
feature validated using
performance standard
testing, detects auditory
thresholds and partnered
with a smartphone app,
delivers user-customized
auditory signal/sound
through the hearing aid. | The Ear ID feature in the subject
device yields hearing assessment
which then calculates and applies
NAL-NL2 target gains to self-fitting
hearing aid using the app in user
smartphone.
Human factors assessment validates
that the user can effectively utilize
the proprietary Ear ID feature to
profile their hearing needs and thus
'calibrate' the device to their unique
hearing profile.
In measures of clinical effectiveness,
the subject device performance in
quantitative and qualitative measures
is consistent with the reference device
and does not raise different issues
regarding safety and effectiveness |
| Mobile App | Mobile application on a smart
device (phone or tablet) with
either iOS or Android
platforms. | Mobile application on a smart
device (phone or tablet) with
either iOS or Android platforms. | | The subject and predicate device
utilize a mobile app user interface on a
smart device in a similar manner and
do not raise different issues regarding
effectiveness. |
| Remote firmware
updates | The subject device via the
Nuheara app allows for
remote firmware updates to
the hearing aids. | The predicate does allow for
remote firmware updates. | Allowing for remote firmware updates
are assessed as part of the
cybersecurity risk process and risk
mitigations are developed per the
device hazard analysis. This does not
raise different questions of safety and
effectiveness. | |
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NUHEARA
IQbuds 2 PRO Hearing Aid
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Image /page/8/Picture/0 description: The image contains the logo for Nuheara. The logo consists of the word "NUHEARA" in bold, sans-serif font. Above the word is a stylized "N" formed by vertical bars of varying heights, resembling a sound wave or equalizer graphic. The logo is simple and modern, using a monochrome color scheme.
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Image /page/9/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized letter N with vertical bars on either side, resembling a sound wave. Below the symbol is the word "NUHEARA" in a bold, sans-serif font.
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Image /page/10/Picture/0 description: The image shows the logo for Nuheara. The logo consists of the word "NUHEARA" in a bold, sans-serif font. Above the word is a stylized "N" formed by three vertical bars of varying heights, resembling sound waves. The logo is simple and modern, with a focus on the company name and a visual representation of sound.
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Image /page/11/Picture/0 description: The image shows the logo for Nuheara. The logo consists of the word "NUHEARA" in bold, sans-serif font. Above the word is a stylized "N" symbol, which is made up of vertical bars of varying heights. The logo is simple and modern, and the black and white color scheme gives it a clean and professional look.
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Image /page/12/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized letter N, with vertical bars on either side, resembling a sound wave. Below the symbol is the word "NUHEARA" in a bold, sans-serif font.
| Electro-Acoustic Characteristics per ANSI S3.22 and CTA 2051:2017 | ||||
|---|---|---|---|---|
| Electro-Acoustic | ||||
| Characteristics | Subject Device | Predicate | Reference | |
| BHA100 Series Braun Clear | Discussion of Differences | |||
| Latency | ||||
| Clause 4.8 | 5ms | Less than or equal to 15 ms | The subject device meets the | |
| requirements, same as predicate. | ||||
| Frequency response | 200Hz - 8000 Hz | 200Hz - 8000 Hz | The subject device has the same | |
| frequency response as the | ||||
| predicate. | ||||
| Input Distortion | ||||
| Clause 4.4.2 | Less than or equal to 5% | |||
| (measure is 0.7%) | Less than or equal to 5% | Non-applicable | The subject device meets the | |
| requirements, same as predicate. | ||||
| Equivalent Input | ||||
| Noise (EIN) | ||||
| Clause:6.12 | 28.5 dB SPL | 26 dB | The subject device meets the | |
| requirements, same as predicate. | ||||
| Harmonic Distortion | ||||
| Clause 6.11 | 0.2% | Less than or equal to 5% | The subject device meets the | |
| requirements, same as predicate. | ||||
| Max OSPL90 | ||||
| Clause 6.2 | 109.6 dB SPL | 115 dB SPL | 120 dB SPL | The subject device meets the |
| requirements, same as predicate. | ||||
| HFA OSPL90 | ||||
| Clause 6.3 | 100.9 dB SPL | 112 dB SPL | 111 ± 2 dB SPL | The subject device meets the |
| requirements and is lower than the | ||||
| predicate device, which does not | ||||
| introduce any questions of safety. | ||||
| HFA FOG | ||||
| Clause 6.5 | 29.4 dB SPL | 43 dB | $40\pm2$ dB | The subject device meets the |
| requirements and is lower than the | ||||
| predicate device, which does not | ||||
| introduce any questions of safety. | ||||
| RTG | ||||
| Clause 6.7 | 24.4 dB SPL | 36 dB | $34 \pm 4$ dB | The subject device meets the |
| requirements and is lower than the | ||||
| predicate device, which does not | ||||
| introduce any questions of safety. |
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Image /page/13/Picture/0 description: The image shows the logo for Nuheara. The logo consists of the word "NUHEARA" in bold, sans-serif font. Above the word is a stylized "N" formed by three vertical bars of varying heights. The logo is in black and white.
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Image /page/14/Picture/0 description: The image shows the logo for Nuheara. The logo consists of two parts: a stylized symbol and the company name. The symbol is above the name and features a bold "N" with vertical bars on either side, resembling sound waves. The company name "NUHEARA" is written in a bold, sans-serif font below the symbol.
510(k) Premarket Notification K221064
8. Non-Clinical Performance Data
Both the subject and predicate devices were tested for conformity to the following FDA recognized consensus standards applicable to the self-fitting hearing aid for its intended use.
Biocompatibility
- ISO 10993-1 Biological evaluation of medical devices .
- ISO 10993-12 Biological evaluation of medical devices ●
- ISO 10993-5 Biological evaluation of medical devices ●
- ISO 10993-10 Biological evaluation of medical devices ●
Electro-Acoustics
- ANSI/ASA S3.22 2014 Measurements ●
- CTA 2051: 2017 ●
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Image /page/15/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized letter "N" with sound wave-like bars on either side, positioned above the word "NUHEARA" in a bold, sans-serif font. The entire logo is in black against a white background.
510(k) Premarket Notification K221064
In order to establish substantial equivalence to the predicate device, Nuheara evaluated the electroacoustic data as found in the predicate and required under Special Controls for 21 CRF §874.3325. As seen in the Electro-Acoustic Characteristics per ANSI S3.22 and CTA 2051:2017 table above, the measurement for the specific cited clauses indicates that the Nuheara IQbuds 2 PRO Hearing Aids are substantially equivalent in acoustic performance to the predicate, Bose Hearing Aid (DEN180026).
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Image /page/16/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized "N" formed by vertical bars of varying heights, resembling a sound wave. Below the symbol is the word "NUHEARA" in a bold, sans-serif font.
Electrical Safety, EMC, Battery Safety, Software and Labeling
- IEC 60601-1; 2005 + AMDI:2012.
- IEC 60601-1-2; 2014, AMDI:2020;Part 1-2:
- IEC 60601-2-66:20191
- · IEC 62133-2, Edition 1.0: 2017-02
- · ISO 15223-1:2016 Medical devices
- · IEC62304: 2006; 1st Edition +A1:2016; Software life cycle processes
Consistent with the predicate device, the Nuheara IQbuds 2 PRO Hearing Aids passed all relevant non-clinical performance testing and biological endpoints, namely cytotoxicity (ISO 10993-05:2009) sensitization, and intracutaneous reactivity (ISO 10993-10:2010).
Similarly, software verification and validation, testing to established consensus standards for electrical safety, EMC and battery safety demonstrated mitigation of risks to an acceptable level as well as reasonable assurance of safe and effective device non-clinical performance, consistent with the predicate, the Bose Hearing Aid.
9. USABILITY TESTING AND CLINICAL PERFORMANCE DATA
Usability Testing
In the usability analyses, preliminary analysis along with design changes intended to reduce the identified use-related risks were implemented iteratively throughout the product development process. Analytical methods were used to identify 'critical/essential' tasks.
Eighteen adults (18 yrs. and older) with a perceived mild to moderate hearing loss hearing loss were enrolled after passing screening of inclusion/exclusion criteria. Task driven Formative Evaluations followed by an inclusive Evaluation were conducted in a one-on-one quiet, comfortable room fit with two chairs and a table on which the participants could handle the device and a smartphone. Informed Consent was obtained for each participant before enrollment and all sessions were video-taped.
While no tasks were identified that met the criteria for 'critical' there were 3 deemed 'essential' (device is not hearing protection and other warnings/cautions from the User Guide). An independent, trained moderator conducted each session which involved a series of steps for accessing, fitting and then using the hearing aid in simulated use conditions. All participants were scored on status of completion of all steps in each of the tasks. A cross-functional team reviewed outcomes at frequent intervals and addressed changes to be considered to labeling, product packaging, and iterative minor
1 Not FDA recognized but applicable to the device and its intended use; also included to be consistent with predicate, Bose Hearing Aid.
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Image /page/17/Picture/1 description: The image shows the logo for Nuheara. The logo consists of a stylized "N" formed by vertical bars of varying heights, resembling sound waves. Below the symbol is the word "NUHEARA" in bold, sans-serif capital letters.
510(k) Premarket Notification K221064
design changes to the user interface to accommodate the user needs. The same crossfunctional team reviewed and approved the Summative Evaluation Report. The evaluation provided evidence that the device was safe and effective to operate by the intended user when used in accordance with its intended use.
Overall, the human factors study demonstrated that the usability of the Nuheara hearing aid was analyzed, verified, and validated for its intended use, intended use environment and the implemented mitigations for user training and device labeling are adequate.
Clinical Performance
Clinical Performance with the Nuheara IQbuds 2 PRO Hearing Aid was assessed with a prospective investigation of the clinical effectiveness with the Nuheara IQbuds 2 PRO self-fitting hearing using standard audiological assessment metrics in 43 adults, mean age of 50 and self-identified with a perceived mild to moderate hearing loss. They were evaluated using well established clinical measures and real-world scenarios. This validation of the Nuheara self-fitting methodology for the target population (adults with perceived mild to moderate hearing loss) used an assessment approach similar to that of the reference BHA100 Series Braun Clear Hearing Aid by assessing clinical effectiveness quantitatively and qualitatively. Those measures involved the following:
- Quantitatively comparing target gain from the audiologist determined REM using . standard audiologic practice (NAL-NL2) against the participant completed self-fit using the Nuheara Ear ID feature.
Image /page/17/Figure/8 description: The image contains three line graphs showing REIG rel-Targets (dB) on the y-axis and Frequency (Hz) on the x-axis. The graphs represent different sound pressure levels: 55dB SPL, 65dB SPL, and 80dB SPL. Each graph displays a black line with blue dashed lines above and below, along with two horizontal orange lines. Additionally, the 80dB SPL graph has two vertical dotted lines at approximately 3500 Hz and 5950 Hz.
This figure shows the REIG calculated deviations measures and corresponding 95% confidence intervals, based on the t-score method. The figure shows that REIG lies with ± 5 dB from NAL-NL2 target for frequencies below 3.5 kHz.
- Assessing perceptual measures of device effectiveness by utilizing the well . characterized and validated APHAB and SSQ-12 self-reported questionnaires and EMA for real-time self-reporting of user listening experience while aided
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Image /page/18/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized "N" formed by three vertical bars of varying heights, with the middle bar forming the letter "N". Below the symbol is the word "NUHEARA" in a bold, sans-serif font. The logo is simple and modern, and the use of the "N" symbol makes it easily recognizable.
510(k) Premarket Notification K221064
(shown below).
A Real Ear Insertion Gains measure (REIG) allowed for amplification levels calculated and applied by Ear ID™ to be compared to the targeted NAL-NL2 prescription. The results indicate that when averaged across the group, the Ear ID™ provides acceptable margins of amplification, within ± 5 dB range, from prescribed targets.
APHAB
The Ear ID feature of the IQbuds 2 PRO was developed and validated by National Acoustics Laboratories (NAL) to the widely recognized hearing aid fitting algorithm, NAL-NL2. This fitting strategy has been incorporated and validated in multiple clinical studies as the primary 'comparator' representing a best fit (e.g., Valente et al., 2018). In the IQbuds 2 PRO clinical performance assessment, the APHAB was used to compare participant subjective outcomes in the unaided and aided conditions.
Clinical effectiveness of the IQbuds 2 PRO Self-Fit hearing aid is evidenced in the analysis of the four subscales of the APHAB questionnaire (Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV) of sound). The results of the 43 subjects in a global score are shown on the table below. The global scores are calculated as the average of the EC, BN, and RV subscale scores.
| UNAIDED | AIDED | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| EC | BN | RV | AV | Global | ||||||
| Score | EC | BN | RV | AV | Global | |||||
| Score | ||||||||||
| Mean | 22.4 | 45.1 | 31.8 | 41.9 | 33.1 | 14.3 | 28.3 | 23.6 | 41.2 | 22.1 |
| SD | 19.1 | 19.1 | 18.7 | 23.9 | 16.9 | 16.3 | 17.8 | 17.4 | 26.8 | 15.3 |
| N | 43 | 43 | 43 | 43 | 43 | 43 | 43 | 43 | 43 | 43 |
This table shows the mean scores for the 43 subjects from the study of clinical performance in each of the APAB subscales and then the overall Global Score. Benefit is derived by comparing unaided to aided values.
Results indicated the Nuheara Self-Fit aided condition improved the mean scores (i.e., lower scores) for ease of communication in noise by 17.8 points; in quiet by 7.4 points; and in reverberation - 8.2 points, out of a total score of 100. The global improvement was 11 points better when aided with the IQbuds 2 PRO Self-Fit. The Unaided to Aided difference in the scores were well within the published 5-30 (%) percentile norms for the APHAB (Cox and Alexander, 1995).
As the IQbuds 2 PRO Self-Fit is based on NAL-NL2, it is appropriate to look at other studies of hearing aids programmed to meet that industry standard formula with REM confirmation and incorporating the APHAB as a measure of clinical effectiveness. The most significant to date would be Valente M. et al., 2018, which had a similar study
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Image /page/19/Picture/0 description: The image shows the logo for Nuheara. The logo consists of a stylized letter N with vertical lines on either side, resembling sound waves. Below the symbol is the word "NUHEARA" in a bold, sans-serif font. The logo is in black and white.
population across multiple criteria and also incorporated a 4-week aided, home trial. Their study showed a significant advantage for the NAL-NL2 fitted subjects (compared to manufacturer default fit) with a significant median advantage of 4.2% (p