(292 days)
No
The description focuses on a self-fitting strategy based on user input and predefined options, not on adaptive learning or complex pattern recognition typically associated with AI/ML in this context. The "self-fitting strategy" appears to be a rule-based system or selection from a fixed set of profiles.
Yes
The device is described as a "wearable sound amplifying device that is intended to compensate for impaired hearing," which aligns with the definition of a therapeutic device as it treats or compensates for a medical condition (impaired hearing).
No
Explanation: The device is a hearing aid intended to amplify sound for individuals with hearing impairment. While it involves a self-fitting process which includes an "assessment" phase where the user selects a hearing profile, this assessment is for customizing the hearing aid's settings, not for diagnosing a medical condition. The device description states it is a "wearable sound amplifying device that is intended to compensate for impaired hearing," which is a treatment, not a diagnosis.
No
The device description explicitly states that the Lumen 155-SF is a "Behind-The-Ear (BTE) hearing aid consisting of the Intricon hardware and Sentibo software". While the software is a key component for self-fitting, the device itself includes physical hardware (the BTE hearing aid).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Lumen® 155-SF hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing. It works by amplifying sound in the environment and delivering it to the user's ear.
- No Biological Samples: The device does not interact with or analyze any biological samples from the user. Its function is purely related to processing and amplifying external sound.
- Intended Use: The intended use clearly states it's for amplifying sound for individuals with perceived mild to moderate hearing impairment. This is a functional aid, not a diagnostic test.
The device is classified as a Class II medical device (specifically a self-fitting wireless air conduction hearing aid) and is intended for over-the-counter sales. This classification and intended use are consistent with a hearing aid, not an IVD.
N/A
Intended Use / Indications for Use
The Lumen® 155-SF self-fitting, wireless air conduction 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. The device is intended for over-the-counter sales without the assistance of a hearing health care professional.
Product codes
QUH
Device Description
Per 21 CFR 874.3325 a self-fitting wireless 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. Self-fitting wireless air conduction hearing aids are class II medical devices.
The Lumen 155-SF self-fitting hearing aid(s) with Sentibo application is a self-fitting wireless air conduction Behind-The-Ear (BTE) hearing aid consisting of the Intricon hardware and Sentibo software to be used on an Apple mobile device (mobile device not included) including wired lightning connector Apple EarPods for the assessment (not included) designed for a single user. The Sentibo app is available only on iOS. The Lumen 155-SF self-fitting OTC hearing aid(s) with Sentibo application is a behind the ear device that includes self-adjustable coupling by means of a slim tube and ear tip/open dome. The hearing aids can be fine-tuned by the user or remotely at the request of the user via the use of QR codes. Once the hearing aids are switched on, the software (Sentibo app) is required for the initial set-up, which is done via the smart phone and requires Apple EarPods with lightning connector to complete (not included). The Sentibo self-fitting software allows the consumer to self-select a hearing profile from a list of options by listening to digitized speech embedded in the software while scrolling through the hearing profiles in real-time through the Apple EarPods. After the setting is selected, the settings can be transferred from the smart phone to the hearing aid directly, though direct audio streaming from the smart phone to the hearing aid is unsupported with the Lumen 155-SF firmware. All Sentibo settings are stored in the application itself, and no internet service is required to perform the self-fitting. The Sentibo application provides 24 predefined options. At the conclusion of the assessment, the software will program hearing aids wirelessly and the user will wear the hearing aids per normal use. The smartphone app will function as a software accessory, allowing the user to make minor adjustments to the hearing aids. The hearing aid is intended to be used with the Sentibo App and to be worn and removed daily by the end user.
The hearing aid makes long term/permanent contact with the skin in and around the ear. The body of the hearing aid rests on the outer shell of the ear (behind the ear) and is coupled to a dome via a slim tube that is worn inside of the ear canal. The materials used in the construction of the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application are biocompatible presenting no biological risk; thus, the requirements of ISO 10993-1 have been met.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear (inside and behind)
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
User (self-fitting) for over-the-counter sales without the assistance of a hearing health 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
Study Design: Multicenter, prospective, randomized, single-blind, parallel-arm study comparing outcomes of two fitting approaches: self-fitting with Sentibo OTC mobile app (Self-fit) or licensed professional fitting (Pro-fit) with the same hearing aid device.
Sample Size: Participants included 93 adults self-identified with perceived mild-to-moderate hearing loss. (92 participants provided data for analyses due to 3 dropouts)
Data Source: Clinical trial participants. Data was collected through video conference calls and email due to COVID-19.
Annotation Protocol:
Participants were screened for inclusion/exclusion criteria.
All participants were required to provide an audiogram and otoscopic clearance obtained by a licensed professional within 6 months of their consent date.
Exclusion criteria: history of significant middle ear disease, surgical remediation of the ear, congenital anomaly; significant discrepancy between self-reported mild-to-moderate hearing loss and the audiological report (e.g., profound hearing loss).
Participants were randomly assigned to either the self-fit (Self-fit) or the pro-fit (Pro-fit) group.
Summary of Performance Studies
Study Type: Clinical Performance Study: Multicenter, prospective, randomized, single-blind, parallel-arm study comparing outcomes of two fitting approaches: self-fitting with Sentibo OTC mobile app (Self-fit) or licensed professional fitting (Pro-fit) with the same hearing aid device.
Sample Size: 92 participants provided data for analyses (45 in Self-Fit group, 47 in Pro-Fit group).
AUC: Not Found
MRMC: Not Found
Standalone Performance:
Self-fit group:
- Satisfaction with sound quality (mean): 2.84 (SD=0.93)
- Satisfaction with fitting process (mean): 3.22 (SD=0.95)
- SSQ-12 Benefit Score: 6.8 (SD=1.7, Range 1-10)
- APHAB Global Score: 10.0 (SD=17.3, Range -25 - 50)
Pro-fit group: - Satisfaction with sound quality (mean): 2.72 (SD=1.14)
- Satisfaction with fitting process (mean): 3.11 (SD=1.07)
- SSQ-12 Benefit Score: 6.5 (SD=1.5, Range 3-10)
- APHAB Global Score: 12.8 (SD=19.7, Range -25 - 55)
Key Results:
The primary objective of demonstrating noninferiority of satisfaction outcomes of participants using the self-fit Sentibo OTC mobile app (Self-fit) when compared to licensed professional-fit (Pro-fit) hearing aids was met. Both Self-fit and Pro-fit groups yielded similar levels of satisfaction for the sound quality of their hearing aids and with the fitting process.
Secondary objectives related to quality of hearing in typical consumer use, perceived benefit, and satisfaction among naïve and experienced users were assessed using SSQ-12 and APHAB. The results indicated that the two groups had similar levels of perceived benefit.
Exploratory objective of verifying acoustic conditions at the eardrum and validating self-fit app acoustic conditions were assessed via simulated real-ear measures. The actual maximum output SPL for the MPO test among all participants was 101.3 dB SPL. Measured results from the hearing aid in-situ minus the NAL-NL2 targets for soft, medium, and loud inputs showed similar matches to NAL-NL2 targets by frequency for both Pro-fit and Self-fit groups. Bland-Altman analysis showed Pro-fit and Self-fit settings were similar in their resulting SPL at the ear canal.
Usability Testing:
- Fifteen adults (18 yrs. and older) with perceived mild to moderate hearing loss were enrolled.
- Task driven Formative Evaluations followed by an inclusive Summative Evaluation were conducted.
- No tasks were identified as 'critical', but 3 were deemed 'essential'.
- The study demonstrated that the usability of the Lumen 155-SF hearing aid(s) with Sentibo application was analyzed, verified, and validated for its intended use and the implemented mitigations for user training and device labeling are adequate.
Key Metrics
- Satisfaction with sound quality (5-point scale)
- Satisfaction with fitting process (5-point scale)
- SSQ-12 Benefit Score (0-10 scale)
- APHAB Global Score (benefit score)
- Maximum Power Output (MPO) in dB SPL
- Measured versus NAL-NL2 target differences (dB)
Predicate Device(s)
Nuheara IQbuds™ 2 PRO (K221064)
Reference Device(s)
Bose Sound Control (K211008), Bose De Novo (DEN180026)
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 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, 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 17, 2023
Intricon Corporation David Akbari Senior Medical Science, Clinical and Regulatory Affairs Liaison 1260 Red Fox Road Arden Hills, Minnesota 55112
Re: K223911
Trade/Device Name: Lumen 155-SF Regulation Number: 21 CFR 874.3325 Regulation Name: Self-fitting air-conduction hearing aid Regulatory Class: Class II Product Code: QUH Dated: August 31, 2023 Received: September 15, 2023
Dear Dr. Akbari:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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/cdrl-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,
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 Ouality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Lumen 155-SF
Indications for Use (Describe)
The Lumen® 155-SF self-fitting, wireless air conduction 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. The device is intended for over-thecounter sales without the assistance of a hearing health 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
Image /page/3/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of colored dots in shades of blue, green, and gray on the left side. To the right of the dots is the company name, "Intricon," in gray lettering, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray font underneath.
510K Summary For Device
The 510(k) Summary is provided on the following pages as required by 21 CFR 807.92(c).
1. SUBMITTER INFORMATION
| Company Name: | Intricon Inc. |
|---|---|
| Company Address: | 1260 Red Fox Road |
| Arden Hills, MN 55112 | |
| Company Contact: | David Akbari, |
| Senior Medical Science, Clinical and | |
| Regulatory Affairs Liaison | |
| Email: | dakbari@intricon.com |
| Phone/Fax: | 651-587-8347 |
2. DEVICE IDENTIFICATION
| Trade Name: | Lumen 155-SF Self-Fitting Hearing Aids
with Sentibo Application |
|----------------------|--------------------------------------------------------------------|
| Generic Device Name: | Hearing Aid |
| Classification Name: | Self-Fitting, Air-Conduction Hearing Aid
Over the Counter |
| Regulation Class: | Class II |
| Product Code: | QUH |
| Assigned K-number: | K223911 |
| Regulation Number: | 21 CFR 874.3325 |
| Panel: | Ear, Nose and Throat Devices |
3. PREDICATE AND REFERENCE DEVICES
Predicate Device: Nuheara IQbuds™ 2 PRO (K221064) Reference Devices: Bose Sound Control (K211008) Bose De Novo (DEN180026) The predicate and reference device(s) have not been subject to a design-related recall.
4. DEVICE DESCRIPTION
Per 21 CFR 874.3325 a self-fitting wireless 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
4
Image /page/4/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name, "Intricon," in gray text, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray text underneath.
to independently derive and customize their hearing aid fitting and settings. Self-fitting wireless air conduction hearing aids are class II medical devices.
Device Characteristics
The Lumen 155-SF self-fitting hearing aid(s) with Sentibo application is a self-fitting wireless air conduction Behind-The-Ear (BTE) hearing aid consisting of the Intricon hardware and Sentibo software to be used on an Apple mobile device (mobile device not included) including wired lightning connector Apple EarPods for the assessment (not included) designed for a single user. The Sentibo app is available only on iOS. The Lumen 155-SF self-fitting OTC hearing aid(s) with Sentibo application is a behind the ear device that includes self-adjustable coupling by means of a slim tube and ear tip/open dome. The hearing aids can be fine-tuned by the user or remotely at the request of the user via the use of QR codes. Once the hearing aids are switched on, the software (Sentibo app) is required for the initial set-up, which is done via the smart phone and requires Apple EarPods with lightning connector to complete (not included). The Sentibo self-fitting software allows the consumer to self-select a hearing profile from a list of options by listening to digitized speech embedded in the software while scrolling through the hearing profiles in real-time through the Apple EarPods. After the setting is selected, the settings can be transferred from the smart phone to the hearing aid directly, though direct audio streaming from the smart phone to the hearing aid is unsupported with the Lumen 155-SF firmware. All Sentibo settings are stored in the application itself, and no internet service is required to perform the self-fitting. The Sentibo application provides 24 predefined options. At the conclusion of the assessment, the software will program hearing aids wirelessly and the user will wear the hearing aids per normal use. The smartphone app will function as a software accessory, allowing the user to make minor adjustments to the hearing aids. The hearing aid is intended to be used with the Sentibo App and to be worn and removed daily by the end user.
Materials of Use
The hearing aid makes long term/permanent contact with the skin in and around the ear. The body of the hearing aid rests on the outer shell of the ear (behind the ear) and is coupled to a dome via a slim tube that is worn inside of the ear canal. The materials used in the construction of the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application are biocompatible presenting no biological risk; thus, the requirements of ISO 10993-1 have been met.
Key Performance Specifications
The hearing aids are used with a replaceable, disposable, 1.45V, size 312 zinc air battery. The digital signal processing on the hearing aids allows for the following features to be adjustable: wide dynamic range compression, 16 frequency bands, noise reduction, feedback cancellation, wind noise suppression, low level expansion and microphone arrays (adaptive and fixed microphone directionality).
5. INTENDED USE/INDICATIONS FOR USE
The Lumen® 155-SF self-fitting, wireless air conduction 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. The device is intended for over-the-counter sales without the assistance of a hearing care professional.
5
Image /page/5/Picture/0 description: The image is a logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left, followed by the company name "Intricon" in gray text. Below the company name, the words "MICROMEDICAL TECHNOLOGY" are written in smaller gray text. The logo is simple and modern, and the use of circles suggests innovation and technology.
6. Labeling
Self-Selection Labeling has been included in the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application product label and Instructions for Use (IFU) to mitigate the risk of improper self-selection. Summarized, it addresses the following:
- Identifying situations in which the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application may help users hear better;
- Identifying situations in which the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application may not be right for users.
- Identifying criteria that indicate users should see a hearing professional. -
- Informing users that the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with -Sentibo Application will not restore normal hearing.
- -Informing users that it is good health practice to have hearing loss evaluated by a licensed healthcare professional.
7. Special Controls
The Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application conforms to the special controls stated in 21 CFR 874.3325.
These requirements are satisfied through following:
- Clinical Performance Validation -
- -Non-clinical Performance Testing
- Summative Usability/Human Factors Validation -
- -Labeling
8. Comparison of Technological Characteristics with the Predicate
The Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application has the same intended use and fundamental technology as the predicate, Nuheara IQbuds 2 PRO (K221064). In the same manner as its predicate, the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application is a user-fitted wireless air-conduction hearing aid intended for over-the-counter use by individuals 18 years or older with perceived mild to moderate hearing impairment. The same fundamental scientific technology is present in both hearing aids to allow the user to control and customize the device to the user's hearing needs. The Sentibo application adds a unique element to the assessment by requiring the use of wired Apple EarPods with lightning connector terminus to perform the assessment, after which settings from the simulated model are transmitted to the hearing aid for use. The use of the Apple EarPods to perform the selfassessment and to transfer settings to the hearing aid has been electro-acoustically verified and performs similarly to the predicate device in terms of its measured acoustic output. The subject device is similar to the predicate in product design, dimension, use of Bluetooth technology and utilizing materials of high standard. The principles of operation of the subject device is explained as equivalent to the predicate. The subject device has no known biocompatibility issues, no known effect on the environment, or to other devices. At a high level, the subject and predicate devices are based on the following technological elements:
- Self-fitting Air Conduction Hearing Aids -
- Wireless Application via Bluetooth -
- -On device controls
- App (Sentibo Application) -
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Image /page/6/Picture/0 description: The image shows the logo for Intricon Micromedical Technology. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the spiral is the company name, "Intricon," in a bold, sans-serif font, with the words "MICROMEDICAL TECHNOLOGY" in a smaller font underneath.
-
Software Platform Compatibility (iOS) -
While both subject and predicate device both have the following elements at a high level, various differences in implementation exist such as the use of rechargeable versus replaceable batteries, and the device embodiment (behind the ear versus in the ear). These differences, where present, do not materially affect the safety or effectiveness of the device. -
Batteries (Replaceable, disposable, 1.45 Volt, Size 312, Zinc Air, Batteries) -
-
Behind-The-Ear (BTE) -
-
Bi-directional Microphones -
-
User-Adjustable Tube Length Selection -
-
-Different size ear tips
-
Feedback Cancellation -
-
16 Channel-wide Dynamic Input Compression -
-
Open Ear Tips in 3 sizes (Small, Medium, Large) -
-
16 channel Noise Reduction -
-
-Requires wired Apple EarPods with lightning connector terminus
Any differences between the subject and predicate device have been addressed through testing to a known performance standard. These differences are not significant and do not impact the effectiveness or safety of the subject device.
The intended use and technological characteristics, (e.g., features, parameter settings etc) are similar to the predicate device (Nuheara IQbuds 2 PRO) cited above. The table below summarizes the characteristics of the Lumen 155-SF Hearing Aids in comparison to the predicate and, as applicable, one of the reference devices. The reference device Bose De Novo (DEN180026) serves a reference specific to the self-fitting strategy (i.e., self-administered hearing test and subsequently applied prescription) and clinical trial design, where the Bose Soundcontrol (K211008) is referenced because it uses the same self-fitting strategy as the Bose De Novo and represents a closer physical embodiment match to the subject device in that both are Behind The Ear (BTE) hearing aids. Since the Bose Soundcontrol is a closer physical match to the subject device, this specific reference device is referred to in the following table along with the predicate device as compared to the subject device for the purpose of demonstrating substantial equivalence.
| Comparison of Subject and Predicate Devices | ||||
|---|---|---|---|---|
| Subject | Predicate | Reference | Discussion of | |
| Differences | ||||
| Device Trade | ||||
| Name | Lumen 155-SF | Nuheara | ||
| IQbuds™ 2 PRO | Bose Sound | |||
| Control | ||||
| 510k Number | K223911 | K221064 | K211008 | |
| Product Code | QUH | QUH | QDD | Same as |
| predicate |
The over-the-
counter (OTC)
version of the self-
fitting hearing aid
has a different
product code |
| Regulation Number | 21 CFR 874.3325 | 21 CFR 874.3325 | 21 CFR 874.3325 | (QUH) to
differentiate it from
the direct-to-
consumer (DTC)
version (QDD) as
used in the Bose
Soundcontrol
(K211008)
reference device. |
| Regulation Name | Self-fitting air
conduction hearing
aid | Self-fitting air
conduction hearing
aid | Self-fitting air
conduction hearing
aid, prescription | Same as
predicate |
| Intended Use | The Lumen 155-SF
self-fitting, wireless
air conduction
hearing aids with
Sentibo application
are intended to
amplify sound for
adults 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. The
device is intended for
over-the-counter
sales without the
assistance of a
hearing care
professional. | The Nuheara
IQbuds 2 PRO
Hearing Aids are
intended to amplify
sound for
individuals 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 | 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 | Similar to
predicate and
reference Bose
Soundcontrol
(K211008)
The clause "no
pre-programming
or hearing test is
necessary" was
omitted in the
subject device as
redundant in the
context of a self-
fitting hearing aid. |
| Indications for
Use | The Lumen 155-SF
Hearing Aids are
intended to amplify
sound for adults 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
over-the-counter
sales without the
assistance of a | professional.
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 | professional.
The Bose
SoundControl
Hearing Aids are
intended to amplify
sound for adults 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- | Same as
predicate and
reference Bose
Soundcontrol
(K211008) |
| | hearing care
professional. | device is intended
for over-the-
counter sale and
use without the
assistance of a
hearing care
professional | for over-the-
counter sales
without the
assistance of a
hearing care
professional. | |
| Technology
(batteries) | 312 zinc-air [non-
rechargeable]
hearing aid batteries | Rechargeable
Lithium- ion
polymer batteries | 312 zinc-air [non-
rechargeable]
hearing aid
batteries | Same as
reference Bose
Soundcontrol
(K211008)
Subject device
battery is non-
rechargeable while
the predicate is a
rechargeable. The
predicate Nuheara
IQbuds 2 PRO
(K211064)
recharges by use
of an AC plug
adapter and
connector to
recharge, and
cannot be used
while charging.
The subject device
uses disposable
zinc-air 312
batteries with drain
noted in the ANSI
S3.22 standard.
The difference in
batteries does not
introduce new
questions of safety
as both devices
meet the
respective
performance
requirements for
battery drain based
on the technology
used. |
| Housing | Image: Behind-the-ear (BTE) | Image: In-the-ear (ITE) hearing aid | Image: Behind-the-ear (BTE) | Same as
reference Bose
Soundcontrol
(K211008)
Although the
subject device
hearing aid |
7
Image /page/7/Picture/0 description: The image shows the Intricon logo. The logo consists of a spiral of blue, green, and gray dots on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller, gray font.
8
Image /page/8/Picture/0 description: The image shows the logo for Intricon Micromedical Technology. The logo consists of a spiral of blue, green, and gray circles on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller, gray font.
9
Image /page/9/Picture/0 description: The image shows the Intricon logo. The logo consists of a spiral of blue, green, and gray circles on the left, followed by the word "Intricon" in gray. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller, gray font.
| | hearing aid housing.
Separate left and
right ear units
(earbuds) with user
control push buttons
on each unit.
Sold in pairs | 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)
Sold in pairs | hearing aid
housing. Separate
left and right ear
units (earbuds)
with user control
push buttons on
each unit.
Sold in pairs | behind-the-ear
style instead of an
in-the-ear style, the
difference in
housing does not
raise different
questions of safety
or effectiveness
since both are
tested to the same
electroacoustic
standards
(ANSI/ASA S3.22
via reference in
ANSI/CTA 2051). |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Input signal
compression | Multichannel, wide
dynamic range
compression | Wide dynamic
range compression | Multichannel, wide
dynamic range
compression | Same as
reference Bose
Soundcontrol
(K211008)
The subject,
predicate, and
reference devices
all feature a form of
wide dynamic
range
compression. The
way in which
frequency sub-
divisions are used
by the processing
algorithm do not
raise different
questions of safety
or effectiveness
since both subject
and predicate
Nuheara IQbuds 2
PRO (K221064)
devices are tested
to the same
electroacoustic
standards. |
| Microphones | Omnidirectional or
Direction modes | Omnidirectional or
Direction modes | Omnidirectional or
Direction modes | Same as
predicate and
reference Bose
Soundcontrol
(K211008) |
| Battery Life | 100 hours
(312 zinc-air [non-
rechargeable] hearing
aid batteries) | Per CTA 2051
(4.1-4.17) Battery
life of up to 8 hrs | 56 hours
Up to 4 days,
assuming 14hr day
usage.
(312 zinc-air [non-
rechargeable] | Same as
reference Bose
Soundcontrol
(K211008) |
| | | | hearing aid
batteries) | Battery drain
differs between
rechargeable and
disposable
batteries and does
not raise any
different issues of
safety and
effectiveness. |
| Noise Reduction | The Lumen 155-SF
features multi-layered
adaptive noise
reduction with
selectable intensity
(Low 7 dB, Medium
10 dB, High 13 dB,
Max 17 dB) | Hybrid Active
Noise Cancellation | Steady state noise
reduction | The subject device
performs in a
similar manner to
the predicate
Nuheara IQbuds 2
PRO (K221064)
and reference
device Bose
Soundcontrol
(K211008) by
reducing hearing
aid output in
response to
detected noise
signals. The
method of
detection and
amount of gain
reduction in
response to
environmental
noise utilize
different
proprietary
methodologies and
were considered in
context in the
clinical data for the
subject, predicate,
and reference
devices. The
specific algorithm
differences do not
raise different
issues of safety
and effectiveness. |
| Self-fitting
method | User selects their
preferred audio
settings by listening
to a smartphone
using Apple lightning
connector wired
EarPods. Users
audition their
preferred settings
based on predefined
set of 24 options | Device uses a
proprietary Ear ID,
a validated NAL-
NL2 fitting
algorithm | Adequate for fitting
moderate hearing
loss (55 dB HL) as
prescribed by NAL-
NL2 | The predicate
Nuheara IQbuds 2
PRO (K221064)
device uses the
NAL/NL2 self-fitting
method which
depends on the
acquisition of pure
tone audiometric
thresholds,
whereas the |
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Image /page/10/Picture/0 description: The image contains the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray dots on the left side. To the right of the dots is the company name "Intricon" in gray, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray font underneath.
11
Image /page/11/Picture/0 description: The image shows the logo for Intricon Micromedical Technology. The logo consists of a spiral of blue, green, and gray circles on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in smaller gray letters.
| | | subject device's
functionally similar
self-fitting method
uses digitized
human voice. The
subject device's
fitting method is
adequate for fitting
mild to moderate
hearing loss, the
same as
prescribed by NAL-
NL2. Sentibo OTC
provides 24
predefined options.
In the subject
device, Apple
EarPods are
required while they
are not required for
either predicate
Nuheara IQbuds 2
PRO (K221064) or
reference devices.
The subject device
has been
measured and
validated in-situ to
demonstrate that
the EarPod
presented running
speech range is
the basis by which
the hearing aid
also performs
when used with its
volume control and
input-controlled
compression.
Because the
subject device
meets the same
electroacoustic test
standards as the
predicate and
reference devices,
no different
questions of safety
or effectiveness
are introduced
despite the
technological
differences in fitting |
|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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Image /page/12/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name, "Intricon," in gray text, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray text underneath.
| Mobile App | Mobile application on
a smart device
(phone or tablet) with
iOS platform | 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 | Similar to
Predicate and
Reference Device
Bose
Soundcontrol
(K211008), except
subject device is
not compatible with
Android platform |
|-------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Remote
firmware
updates | Not supported | The subject device
via the Nuheara
app allows for
remote firmware
updates to the
hearing aids. | The hearing aids
update
automatically when
connected to the
Bose Hear app.
Follow the app
instructions. | Subject device
does not allow for
remote firmware
updates
While the subject
device does not
support remote
firmware updates
and both the
predicate Nuheara
IQbuds 2 PRO
(K221064) and
reference device
Bose Soundcontrol
(K211008) do, the
subject, predicate,
and reference
device all conform
to similar wireless
recognized
consensus
standards. Since
the subject device
does not allow the
potential for
firmware
modification
wirelessly, no new
questions of safety
or effectiveness
are introduced. |
13
Image /page/13/Picture/0 description: The image shows the Intricon logo. The logo consists of a spiral of blue, green, and gray circles on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller font.
Electro-Acoustic Characteristics per ANSI/ASA S3.22 and ANSI/CTA 2051:2017 (and ANSI/ASA S3.22 by reference)
| | Subject | Predicate | Reference | Discussion of
Differences |
|------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade
Name | Lumen 155-SF | Nuheara
IQbuds™ 2 PRO | Bose Sound
Control | Same as predicate
Nuheara IQbuds 2
PRO (K221064)
within measurement
uncertainty
tolerance. The
subject, predicate,
and reference Bose
Soundcontrol
(K211008) devices
all have
programmable
latency, and all are
less than or equal to
15 ms as specified
in ANSI/CTA 2051. |
| 510k Number | K223911 | K221064 | K211008 | |
| Latency clause
4.8 | 5.8 ms | 5 ms | 5.5 ms | |
| Frequency
response | 5 years smartphone
experience / # with 15db at 500Hz, 1000Hz and 2000Hz,
** Average PTA at 500Hz, 1000Hz, 2000Hz and 4000Hz is >15dB between ears
Figure 2 shows the means and standard deviations at each audiometric test frequency for each group. No significant differences were found between groups at any test frequency.
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Image /page/22/Picture/0 description: The image shows the Intricon logo. The logo consists of a spiral of blue, green, and gray circles on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller, gray font.
Figure 2. Audiometric Thresholds
Image /page/22/Figure/4 description: The image shows a graph of average air conduction audiograms versus frequency. The x-axis represents frequency in Hertz (Hz), with values ranging from 250 to 8000. The y-axis represents air conduction threshold in decibels Hearing Level (dB HL), ranging from -90 to 0. Two groups are compared: Pro-Fit and Self-Fit, with error bars indicating one standard deviation from the mean.
Average Air Conduction Audiograms versus Frequency (Hz)
Study Results
The primary objective of this study was to demonstrate the noninferiority of outcomes for participants who use new hearing aids that have been programmed with the self-fit Sentibo OTC mobile app (Self-fit) versus hearing aids that have been programmed by an audiologist using commercially available fitting software (Pro-fit). Both Self-fit and Pro-fit groups yielded similar levels of satisfaction for the sound quality of their hearing aids (Figure 3) and with the fitting process (Figure 4).
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Image /page/23/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray dots on the left side. To the right of the dots is the company name, "Intricon," in gray lettering, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray letters underneath.
Image /page/23/Figure/3 description: The image shows the title of a figure. The title is "Figure 3. Responses to the sound quality question."
Image /page/23/Figure/4 description: The image is a bar chart titled "Satisfaction with Sound Quality". The x-axis shows the satisfaction levels: Very Dissatisfied, Dissatisfied, Neither, Satisfied, and Very Satisfied. The y-axis shows the count, ranging from 0 to 25. The chart compares the satisfaction levels between the Pro-Fit Group and the Self-Fit Group.
Figure 4. Responses to the fitting process question.
Image /page/23/Figure/6 description: This bar graph shows the satisfaction with the fitting process. The x-axis shows the satisfaction levels: Very Dissatisfied, Dissatisfied, Neither, Satisfied, and Very Satisfied. The y-axis shows the count from 0 to 25. The Pro-Fit group and Self-Fit group are compared at each satisfaction level.
24
Image /page/24/Picture/0 description: The image shows the logo for Intricon. The logo consists of a spiral of blue, green, and gray circles on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller font.
Question 1
- Pro-fit mean of 2.72 (SD=1.14) -
- Self-fit mean of 2.84 (SD=0.93) -
Question 2
- Pro-fit mean of 3.11 (SD=1.07) -
- Self-fit mean of 3.22 (SD=0.95) -
Figures 5 and 6. Comparison of the overall scores for the two questions.
Image /page/24/Figure/10 description: The image contains two boxplots comparing satisfaction scores between Pro-Fit and Self-Fit groups. The left boxplot shows satisfaction with sound quality, while the right boxplot shows satisfaction with the fitting process. Both boxplots display satisfaction scores on the y-axis, ranging from 0 to 4.5, and the Pro-Fit and Self-Fit groups are represented on the x-axis, with blue and red boxes, respectively.
The secondary objectives were to evaluate the quality of hearing in typical consumer use, to evaluate the participants' perceptions of benefit, to assess satisfaction among naïve and experienced users, and to estimate the rate of device-adverse events. Results from the SSQ-12 and APHAB appear in Table 4.
| | Self-fit
Mean (SD, Range) | Pro-fit
Mean (SD, Range) |
|----------------------|------------------------------|-----------------------------|
| SS Questionnaire #1 | 2.8 (0.9, 0 - 4) | 2.7 (1.1, 0 - 4) |
| SS Questionnaire #2 | 3.2 (1.0, 0 - 4) | 3.1 (1.1, 0 - 4) |
| SSQ-12 Benefit Score | 6.8 (1.7, 1 - 10) | 6.5 (1.5, 3 - 10) |
| APHAB Global Score | 10.0 (17.3, -25 - 50) | 12.8 (19.7, -25 - 55) |
Table 4. Test results
The SSQ-12 focuses on the listener's perceived ability to perform across twelve different listening environments. The output is an average of all scores that ranged from Not at all (0) to Perfectly (10). The overall mean score for the Self-fit group output scores on the
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Image /page/25/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name, "Intricon," in gray text. Below the company name is the phrase "MICROMEDICAL TECHNOLOGY" in smaller, gray text.
SSQ-12 were 6.8 (SD=1.7) and for the Pro-fit group, 6.5 (SD=1.5), indicating that the two groups had similar levels of perceived benefit.
The scores on the APHAB are determined by calculating the benefit associated with wearing a hearing aid. Participants evaluate their ability in everyday situations both with and without a hearing aid on a seven-point scale. Benefit scores are calculated as a difference between performance with a hearing aid and performance without an aid. The standard outcome for the APHAB is a global benefit score which provides an index of the benefit a person receives from their hearing aid. The overall mean score for the Selffit group was 10.0 (SD=17.3) and for the Pro-fit group, 12.8 (SD=19.7), indicating that the two groups had similar levels of perceived benefit.
The exploratory objective of this study was to quantitatively confirm measured sound pressure levels at the ear canal in order to document safety and examine efficacy. As shown in Figure 7 the actual maximum output SPL for the MPO test among all participants in all conditions was 101.3 dB SPL (n=184 ears). Figures 8, 9, and 10 show measured results from the hearing aid in-situ minus the NAL-NL2 targets for both the Pro-fit and Self-fit groups which resulted in similar matches to NAL-NL2 targets by frequency.
Figure 7. Overall Maximum Sound Pressure, Pro-fit and Self-fit groups combined
Image /page/25/Figure/7 description: The image shows a graph titled "Maximum Power Output, Pro-fit and Self-fit Groups Combined, 85 dB SPL Swept Tone Input". The graph plots frequency in Hz on the x-axis, ranging from 250 to 16000, and dB SPL in KEMAR (IEC 60318-4 Coupler) on the y-axis, ranging from -10 to 140. There are multiple orange lines clustered together, showing a general trend of increasing dB SPL as frequency increases from 250 Hz to around 2000 Hz, then fluctuating between 80 and 100 dB SPL. A dashed black line is also plotted, showing a lower dB SPL value that increases with frequency.
26
Image /page/26/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name, "Intricon," in gray, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray letters underneath.
Figure 8. Measured results from the hearing aid minus NAL-NL2 targets for soft level inputs.
Image /page/26/Figure/4 description: The image is a boxplot comparing 'Pro-fit' and 'Self-fit' hearing aid settings, showing the difference between measured and target values in decibels (dB) across various frequencies in Hertz (Hz). The data represents soft inputs at 50 dB SPL. The x-axis displays frequencies ranging from 250 Hz to 8000 Hz, while the y-axis shows the 'Measured - Target' difference in dB, ranging from -40 to 20. The boxplots indicate the distribution of differences at each frequency for both 'Pro-fit' and 'Self-fit' settings.
27
Image /page/27/Picture/0 description: The image shows the logo for Intricon Micromedical Technology. The logo features a spiral of blue, green, and gray circles on the left. To the right of the spiral is the word "Intricon" in gray, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray font underneath.
Figure 9. Measured results from the hearing aid minus NAL-NL2 targets for medium level inputs.
Image /page/27/Figure/4 description: The image is a boxplot comparing "Pro-fit" and "Self-fit" measurements relative to a target, with "Measured - Target (dB)" on the y-axis and "Frequency (Hz)" on the x-axis. The title indicates "Measured minus Target" for "Mid Inputs (65 dB SPL)". The y-axis ranges from -40 to 20 dB, while the x-axis spans frequencies from 250 to 8000 Hz. The plot shows the distribution of differences between measured and target values for both "Pro-fit" and "Self-fit" at various frequencies.
28
Image /page/28/Picture/0 description: The image contains the logo for Intricon, a micro medical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name "Intricon" in gray, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray font underneath.
Figure 10. Measured results from the hearing aid minus NAL-NL2 targets for high level inputs.
Image /page/28/Figure/4 description: The image is a boxplot comparing the measured minus target values in decibels (dB) for loud inputs at 80 dB SPL across different frequencies in Hertz (Hz). The x-axis represents frequency, ranging from 250 Hz to 8000 Hz, while the y-axis represents the difference between the measured and target values in dB, ranging from -40 dB to 20 dB. The plot compares two conditions, 'Pro-fit' and 'Self-fit', with each frequency having two boxplots showing the distribution of the measured minus target values for each condition.
Figure 11 presents the Bland-Altman analysis for all ears. All participants, regardless of group assignment, provided setting data from both the Self-fit procedure and the Pro-fit procedure. The vertical axis of the graph shows differences within participants between their pro-fit and self-fit settings. The horizontal axis is the average dB SPL of the same person's pro-fit and self-fit settings. The vertical lines between one and two standard deviations are the group mean values for soft, medium, and loud inputs, respectively. Values that fall outside the two standard deviation range towards the top of the graph (pro-fit louder than self-fit) mean that the participant was over-fit relative to their NAL-NL2 generated targets, or simply self-selected softer settings than what would have been prescribed by NAL-NL2. Values that fall outside the two standard deviation range towards the bottom of the graph (Self-fit louder than Pro-fit) mean that some participants at some frequencies had a propensity to select louder than what was prescribed to them via NAL-NL2. Both Pro-fit and Self-fit settings were similar in their resulting SPL at the ear canal, documenting similar efficacy of the fitting techniques despite there being minor differences in the technological characteristics.
29
Image /page/29/Picture/0 description: The image shows the Intricon logo. The logo consists of a spiral of blue, green, and gray dots on the left, and the word "Intricon" in gray on the right. Below the word "Intricon" is the phrase "MICROMEDICAL TECHNOLOGY" in a smaller font.
Image /page/29/Figure/3 description: The image is titled "Figure 11. Bland-Altman analysis of all ears in both Pro-fit and Self-fit groups". The image is a title for a figure. The title describes that the figure is a Bland-Altman analysis.
Image /page/29/Figure/4 description: This figure is a Bland-Altman plot with data from 184 ears. There are 1,880 points per input level, for a total of 5,640 points. The plot shows the difference between Pro-fit and Self-fit (in dB) on the y-axis, and the average of Pro-fit and Self-fit (in dB SPL) on the x-axis. The data is separated into three categories: Soft Input (50 dB SPL), Medium Input (65 dB SPL), and Loud Input (80 dB SPL).
The methodology and design of this study was in line with the clinical evaluation of the reference device Bose De Novo (DEN180026) (subjective and objective performance outcomes). These results were also referenced in the 510(k) Summary for the Bose SoundControl BTE hearing aid (K211008) which is a closer physical embodiment to the subject device in that they are both BTE style hearing aids. The results demonstrate that the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application were noninferior to fitting by an audiologist using best practice fitting algorithms. Effectiveness is also substantially equivalent to the predicate device (Nuheara IQbuds 2 PRO), which was similarly demonstrated to be substantially equivalent to subjective and objective performance outcomes demonstrated in the Bose De Novo (DEN180026) clinical study design referenced by the Bose Soundcontrol (K211008).
This validation of the Sentibo OTC 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 and predicate devices (Bose Soundcontrol K211008 and Nuheara IQbuds™ 2 PRO K221064 respectively).
12. SUBSTANTIAL EQUIVALENCE
30
Image /page/30/Picture/0 description: The image shows the logo for Intricon, a micromedical technology company. The logo features a spiral of blue, green, and gray circles on the left side. To the right of the circles is the company name "Intricon" in gray, with the words "MICROMEDICAL TECHNOLOGY" in smaller gray font underneath.
The Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application has the same intended use as the predicate device, the Nuheara IQbuds 2 PRO (K221064). Like the predicate device, the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application is a user-fitted, wireless, air-conduction hearing aid, intended for over-thecounter use by individuals 18 years or older with perceived mild to moderate hearing impairment. Clinical data shows that the effectiveness of the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application is non inferior to fitting by a licensed audiologist with a calibrated clinical audiometer for both self-fitting hearing assessment. Furthermore, human factor testing displayed a high level of user satisfaction and is therefore substantially equivalent to the predicate device in acoustic performance, usability, and safety. Non-clinical performance testing has been conducted to ensure that the device does not raise any questions of safety and effectiveness as established by the predicate device. Device and application firmware and software have been validated per the same standards as used to validate the device and application firmware and software of the predicate device. Lastly, design verification results demonstrate that the subject device has substantially equivalent performance to the predicate device. Lumen 155-SF Hearing Aids are substantially equivalent in intended use and fundamental scientific technology to the Nuheara IQbuds™ 2 PRO Hearing Aids (K221064) and reference devices Bose SoundControl Hearing Aids (K211008) and Bose De Novo (DEN180026). The Bose De Novo (DEN180026) reference device is leveraged for its clinical study design as it demonstrates the safety and efficacy of the self-fitting strategy, while the Bose Soundcontrol (K211008) is leveraged for its use of the same fitting strategy used in the Bose De Novo while being a closer match to the physical embodiment of the subject device in that they are both BTE hearing aids. The Lumen 155-SF Hearing Aids are considered as safe and effective as the predicate device for its intended use when used in accordance with its Instructions for Use.
13. Conclusion
The special controls for self-fitting hearing aids as per 21 CFR 874.3325, are met in the following aspects; the clinical data has evaluated the effectiveness of the self-fitting strategy, the electroacoustic parameters (including max output limits, distortion levels, self-generated noise levels, latency, and frequency response) were specified and tested, performance data demonstrates the EMC, electrical and thermal safety of the device. The software verification, validation, and hazard analysis has been performed. The wireless technology performance testing has validated safety of exposure to non-ionizing radiation and validation of wireless technology functions. The usability testing has demonstrated that users can correctly use the device as intended under anticipated conditions of use. In conclusion, the evidence provided demonstrates that the outcomes of the Sentibo self-fit model (with Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application) are comparable to an audiologist's best-practice model. Based on the comparison and analysis above, the Lumen 155-SF Self-Fitting OTC Hearing Aid(s) with Sentibo Application is determined to be substantially equivalent to the predicate device (Nuheara IQbuds 2 PRO K221064).