(114 days)
Not Found
No
The description mentions "innovative software that uses the NAL-NL2 programming formula" and a "hearing profile/personalization system" that assesses hearing levels and preferences. While this involves sophisticated algorithms for self-fitting, the summary does not explicitly mention or describe the use of AI or ML techniques like neural networks, deep learning, or training data sets for model development. The focus is on a known programming formula and a rule-based personalization system.
Yes
The device, Concha Sol OTC Hearing Aids, is a therapeutic device intended to amplify sound for individuals with hearing impairment, directly addressing a health condition.
No
The Concha Sol Hearing Aids are intended to amplify sound and assess hearing levels to customize amplification, but their primary purpose is amplification for individuals with perceived hearing impairment, not the diagnosis of a medical condition.
No
The device description explicitly states that the hearing aids include microphones for audio input and a receiver to deliver sound to the ear, which are hardware components. It also mentions the hearing aids are powered by batteries. While there is a mobile application with self-fitting software, the device itself is a physical hearing aid with integrated hardware.
Based on the provided information, the Concha Sol Hearing Aids are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Concha Sol Function: The Concha Sol Hearing Aids are designed to amplify sound for individuals with perceived hearing impairment. They work by receiving sound from the environment, processing it, and delivering it to the user's ear. This is a direct interaction with the user's auditory system, not an analysis of a biological specimen.
- Intended Use: The intended use clearly states "to amplify sound for individuals... with perceived mild to moderate hearing impairment." This is a functional aid, not a diagnostic test.
- Device Description: The description details microphones, receivers, and software for sound processing and amplification. It does not mention any components or processes for analyzing biological samples.
- Performance Studies: The performance studies focus on usability, self-selection, and clinical performance related to speech understanding and hearing aid benefit. These are assessments of the device's effectiveness in its intended function, not diagnostic accuracy based on biological samples.
Therefore, the Concha Sol Hearing Aids fall under the category of a medical device that provides a therapeutic or assistive function, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Concha Sol 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 use without the assistance of a hearing care professional.
Product codes
QUH
Device Description
The Concha Sol OTC Hearing Aids (Model CL-1001) are receiver-in-the ear, self-fitting, wireless air conduction hearing aids (§ 874.3325) intended to amplify sounds in the environment for adult users who have a perceived mild-to-moderate hearing loss. The hearing aids include Ear Tips, Carry Case and the Concha Labs mobile application. The device is indicated for over-thecounter sale (product code QUH) and integrates user input with a self fitting strategy, enabling 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 Self-Fitting hearing aids incorporate microphones for audio input, and sound is delivered to the ear via a receiver that can be coupled with domes.
The mobile application contains a self-fitting software known as Soundscope, an innovative software that uses the NAL-NL2 programming formula used globally by hearing aid manufacturers. The hearing profile/personalization system in the Concha Sol Hearing Aid assesses the individual's hearing levels across a frequency spectrum in order to generate and customize the device's amplification specific to their hearing needs. The self-fitting software also assesses the individual's hearing preferences to help fine-tune the device's amplification. In addition to hearing aid functionality for environmental and directive listening; the hearing aids can also be used for telephony and streaming audio from a Bluetooth® compliant mobile device. The hearing aids are powered using Zinc Air size 312 cell batteries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
user, without the assistance of a hearing care professional. Over-The-Counter Use.
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
The Usability / Human Factors validation test included 15 representative users ranging in age from 25 – 76 (median age of 70) and included 10 females/5 males with 2/3 of all participants aged 60 and above. Five participants self-described a mild hearing loss and 10 indicated a moderate with 9/15 indicating no prior hearing aid experience.
The Self-selection validation study included 27 potential consumers.
The clinical investigation study included 21 participants (13 men, 8 women). Their mean age was 66.2 years (median 73.0 years). 17 users were inexperienced with hearing aids, and 4 were experienced. Audiometric measures were taken to confirm perceived mild-to-moderate hearing status.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Human Factors/Usability:
Study type: Formative Studies (1, 2, and 3) and Summative Human Factors Validation Tests (2 primary studies).
Sample size: 15 representative users (Human Factors/Usability validation test); 27 potential consumers (Self-selection validation study).
Key results:
"After analysis of data per pre-specified 'success' outcomes it was determined that the Concha Sol Hearing Aid and Concha app are able to be used correctly by the intended users under the anticipated condition of use."
Clinical Performance Testing:
Study type: Within-subject, randomized, crossover study design of the clinical investigation.
Sample size: 21 participants.
Key results:
Effectiveness: Quick Speech-in-Noise (QuickSIN) Test and Abbreviated Profile of Hearing Aid Benefit (APHAB) were used. For the clinical study to be deemed successful, the SELF-FIT method needs to yield outcomes (namely QuickSIN and APHAB scores) which are comparable to the CLIN-FIT method, with margins of 1.8 dB for QuickSIN benefit and 9.9 for APHAB. "For both assessed endpoints, the study results indicated comparable performance and satisfaction outcomes as revealed from clinical data as compared to the same hearing aid fit by a clinician."
Safety: "No device-related or other adverse events were observed over the course of the study. Also, no health-related issues due to device fit or discomfort were observed, and no device failures leading to potential safety issues were observed."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
March 15, 2024
Concha Labs % Joseph Burke Regulatory Consultant for Concha Labs Joseph Burke Consulting Inc. 16 Rebekah Lane Sutton, Massachusetts 01590
Re: K233747
Trade/Device Name: Concha Sol Hearing Aids (CL-1001) Regulation Number: 21 CFR 874.3325 Regulation Name: Self-Fitting Air-Conduction Hearing Aid Regulatory Class: Class II Product Code: QUH Dated: February 12, 2024 Received: February 12, 2024
Dear Joseph Burke:
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 (QS) 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 OS 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 (QS) 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 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,
Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
Concha Sol Hearing Aids (CL-1001)
Indications for Use (Describe)
The Concha Sol 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 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)
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3
| 510(k)#: K233747 | 510(k) Summary | Prepared 12 Feb 202- |
|---|---|---|
| 1. CONTACT DETAILS | 21 CFR 807.92 (a)(1) | |
| Concha Labs | ||
| 55 East 3rd Avenue | ||
| San Mateo, CA, 94401 | ||
| Company Contact: Carlos Bullock | ||
| Official Correspondent: Joseph Burke | ||
| 2. DEVICE NAME | 21 CFR 807.92 (a)(2) | |
| Name of Device: Concha Sol OTC Hearing Aids (CL-1001) | ||
| Common Name: Self-fitting OTC Hearing Aid | ||
| Classification Name: Self-fitting Air Conduction Hearing Aid | ||
| Regulation: 21 CFR §874.3325 | ||
| Regulatory Class: II | ||
| Product Code: QUH | ||
| Review Panel: Ear, Nose and Throat Devices |
3. LEGALLY MARKETED PREDICATE DEVICE
Predicate #: K211008 Predicate Trade Name: Bose SoundControl Hearing Aids Product Code: QDD
DEVICE DESCRIPTION SUMMARY 4.
The Concha Sol OTC Hearing Aids (Model CL-1001) are receiver-in-the ear, self-fitting, wireless air conduction hearing aids (§ 874.3325) intended to amplify sounds in the environment for adult users who have a perceived mild-to-moderate hearing loss. The hearing aids include Ear Tips, Carry Case and the Concha Labs mobile application. The device is indicated for over-thecounter sale (product code QUH) and integrates user input with a self fitting strategy, enabling 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 Self-Fitting hearing aids incorporate microphones for audio input, and sound is delivered to the ear via a receiver that can be coupled with domes.
The mobile application contains a self-fitting software known as Soundscope, an innovative software that uses the NAL-NL2 programming formula used globally by hearing aid manufacturers. The hearing profile/personalization system in the Concha Sol Hearing Aid assesses the individual's hearing levels across a frequency spectrum in order to generate and customize the device's amplification specific to their hearing needs. The self-fitting software also assesses the individual's hearing preferences to help fine-tune the device's amplification. In addition to hearing aid functionality for environmental and directive listening; the hearing aids can also be used for telephony and streaming audio from a Bluetooth® compliant mobile device. The hearing aids are powered using Zinc Air size 312 cell batteries.
Prepared 12 Feb 2024
55 East 3rd Avenue San Mateo, CA 94401
21 CFR 807.92 (a)(3)
21 CFR 807.92 (a)(4)
510(k) Sur
4
Image /page/4/Picture/0 description: The image shows the logo for Concha Labs. The logo consists of a yellow stylized seashell-like icon on the left, followed by the text "CONCHA LABS" in a bold, sans-serif font. The text is in a dark gray or black color, providing a strong contrast against the white background.
5. INTENDED USE
21 CFR 807.92 (a)(5)
21 CFR 807.92 (a)(5)
21 CFR 807.92 (a)(6)
The Concha Sol 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 use without the assistance of a hearing care professional.
6. INDICATIONS FOR USE COMPARISON
The indications for use of the subject device are "The Concha Sol 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 preprogramming or hearing test is necessary. The device is intended for use without the assistance of a hearing care professional."
A comparison of the indications for use of the Concha Sol Hearing Aids are similar to those of the predicate device (Bose SoundControl Hearing Aid (K211008)); with the exception of the point of sale. The Bose SoundControl is described as a Direct to Consumer (DTC) device (Product code QDD); whereas the Concha Sol Hearing Aids are indicated for Over the Counter (OTC) sale (Product code QUH). The Concha Sol is also in compliance with all elements of the OTC Hearing Aid Final Rule, as well as compliant with OTC requirements for labeling.
7. TECHNOLOGICAL COMPARISON
The technological characteristics of the Concha Sol Hearing Aids are similar to those of the predicate device Bose SoundControl Hearing AID (K211008). The table below provides a comparison of the subject and predicate devices. A thorough review of these products revealed the devices are equivalent from a technological perspective.
| Subject Device | Predicate | Discussion | |
|---|---|---|---|
| Device Trade Name | Concha Sol | ||
| Hearing Aids | Bose SoundControl | ||
| Hearing Aid | |||
| 510k Number | K233747 | K211008 | |
| Product code | QUH | QDD | Similar to the predicate with |
| exception of the point of sale: | |||
| OTC (Concha) vs. DTC | |||
| (Bose). Subject device | |||
| complies with OTC hearing | |||
| aid requirements outlined in | |||
| 21 CFR 800.30. | |||
| Regulation number | 21 CFR 874.3325 | 21 CFR 874.3325 | Same as predicate |
| Regulation name | Self-fitting air | ||
| conduction hearing | |||
| aid | Self-fitting air conduction | ||
| hearing aid | Same as predicate | ||
| Intended Use | The Concha Sol | ||
| Hearing Aid is | |||
| intended to amplify | |||
| sound for individuals | |||
| with perceived mild to | |||
| moderate hearing | |||
| impairment. | The Bose SoundControl | ||
| Hearing Aid is intended to | |||
| amplify sound for | |||
| individuals with perceived | |||
| mild to moderate hearing | |||
| impairment. | Same as predicate |
5
Image /page/5/Picture/0 description: The image shows a yellow symbol that appears to be a stylized representation of a flame or a drop of liquid with a jagged edge at the top. The symbol is enclosed by two curved lines on either side, resembling parentheses or sound waves. The overall design is simple and abstract, with a focus on the central flame-like shape.
| Indications for Use | The Concha Sol
Hearing Aid is
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
use without the
assistance of a
hearing care
professional. | The Bose SoundControl
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 subject device has
similar Indications for Use
as the predicate device
,with the appropriate
adjustment in accordance
with the OTC Hearing Aid
Final Rule. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Battery | Single use 312 Zinc
Air Batteries | Single use 312 Zinc Air
Batteries | Same as predicate |
| Subject Device | Primary Predicate | Discussion | |
|---|---|---|---|
| Device Trade Name | Concha Sol OTC | ||
| Hearing Aids | Bose SoundControl | ||
| Hearing Aid | |||
| Housing | Behind The Ear (BTE) | ||
| Receiver In Canal | |||
| (RIC) hearing aid | |||
| housing. Separate left | |||
| and right ear units | |||
| with a separate Ear | |||
| Tip for each unit. On | |||
| the device, 'Rocker | |||
| Switch' used to | |||
| control volume. | |||
| Mobile device | |||
| streaming and phone | |||
| audio via Bluetooth. | Behind The Ear (BTE) | ||
| Receiver In Canal (RIC) | |||
| hearing aid housing. | |||
| Separate left and right | |||
| ear units with a separate | |||
| Ear Tip for each unit. On | |||
| device, 'Rocker Switch' | |||
| used to control volume. | Devices are similar with | ||
| only slight dimensional | |||
| differences. | |||
| Input signal | |||
| compression | Wide dynamic range | ||
| compression | Wide dynamic range | ||
| compression | Same as predicate | ||
| Microphones | Microphones may, | ||
| during use, be | |||
| configured by the | |||
| user in omni- | |||
| directional or | |||
| directional modes | Microphones may, | ||
| during use, be | |||
| configured by the user in | |||
| omni-directional or | |||
| directional modes | Same as predicate | ||
| Battery Lifetime | Per CTA 2051 (4.1- | ||
| 4.17) | |||
| Battery life of 5 days, | |||
| 13 hours per day | Per CTA 2051 (4.1-4.7) | ||
| Battery life of 4 days, 14 | |||
| hours per day | The battery life is similar to | ||
| that of the predicate and | |||
| differences raise no new | |||
| questions of safety and | |||
| effectiveness. |
6
Image /page/6/Picture/0 description: The image shows the logo for Concha Labs. The logo consists of a yellow abstract symbol on the left, followed by the words "CONCHA LABS" in a bold, sans-serif font. The text is in a dark gray or black color. The logo appears to be clean and modern.
| Subject Device | Primary Predicate | Discussion / Results | |
|---|---|---|---|
| Device Trade Name | Concha Sol OTC | ||
| Hearing Aids | Bose | ||
| SoundControl | |||
| Hearing Aid | |||
| Self-fitting method | Subject device uses a | ||
| proprietary | |||
| Soundscope | |||
| technology, with initial | |||
| gain parameters | |||
| based on NAL- NL2. | Loudness and Fine- | ||
| tuning app-based | |||
| Controllers. Utilizes | |||
| a proprietary fitting | |||
| method. | Performance testing | ||
| evaluated these differences | |||
| in technology and the results | |||
| support substantial | |||
| equivalence. | |||
| Mobile App | Mobile application on | ||
| a smart device (phone | |||
| or tablet) with an iOS | |||
| operating platform. | Mobile application on a | ||
| smart device (phone or | |||
| tablet) with either iOS or | |||
| Android platforms. | Similar to predicate but | ||
| currently subject device only | |||
| uses iOS operating platform. | |||
| This does not raise new | |||
| issues regarding | |||
| safety and effectiveness. | |||
| Streaming / | |||
| Telephony | Subject device | ||
| provides audio | |||
| streaming and | |||
| telephone via | |||
| Bluetooth. | N/A | Predicate does not include | |
| the features. They do not | |||
| raise new issues of safety or | |||
| effectiveness Performance | |||
| testing evaluated the | |||
| differences in technology | |||
| and the support substantial | |||
| equivalence. | |||
| Electro-Acoustic | |||
| Characteristics | Subject Device | Primary Predicate | Discussion |
| Concha Sol OTC | |||
| Hearing Aids | Bose SoundControl | ||
| Hearing Aid | Compliance to $800.30 | ||
| Latency Clause | 6.7 ms | Less than or equal to 15 | |
| ms | Both devices meet | ||
| requirements | |||
| Frequency | |||
| response | 10000 Hz | 8000 Hz | Both devices meet |
| requirements | |||
| Input Distortion | |||
| Clause | 1.20% | 5% | Both devices meet |
| requirements | |||
| Equivalent Input | |||
| Noise (EIN) | 18.6 dB SPL |