(97 days)
Not Found
No
The description focuses on traditional digital signal processing (WDRC circuit) and programmable memory for amplification characteristics, with no mention of AI or ML algorithms for sound processing or adaptation.
Yes
The device is a hearing aid, which addresses hearing impairment by amplifying sound, thereby providing a therapeutic benefit for individuals with hearing loss.
No
The device is a hearing aid, designed to amplify sound for hearing-impaired persons, which is a therapeutic function, not a diagnostic one. It assists with an existing condition rather than identifying or characterizing a medical condition.
No
The device description explicitly lists multiple hardware components, including an ASIC, microphone, battery, magnetic sensor, mechanical components, removal loop, and seals. While it mentions proprietary software for programming, the core device is a physical hearing aid with hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide hearing assistance by amplifying sound pressure waves and transmitting them to the external ear canal. This is a direct interaction with the patient's body to improve a physiological function (hearing).
- Device Description: The device is a hearing aid, which is a medical device designed to be worn in the ear canal. It contains components for sound processing and amplification.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze biological samples (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
- Anatomical Site: The device is placed in the external ear canal, which is a part of the body, not a sample being tested in vitro.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This hearing aid does not fit that description.
N/A
Intended Use / Indications for Use
The Lyric 2 hearing aid is a disposable, extended-wear air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal the hearing aid is discarded.
Product codes
ESD
Device Description
Lyric2 is a disposable, programmable, deep-canal, extended-wear, air conduction hearing device, It uses an analog, digitally programmable WDRC ("Wide Dynamic Range Compression") circuit with very low power consumption. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The amplification characteristics are contained in digitally programmable memory, and adjustment of device parameters is achieved through the proprietary Fitting System and Software.
The Lyric2 consists of:
- A programmable application specific integrated circuit ("ASIC") for analog signal processing.
- An analog microphone receives sound waves that will be amplified and transmitted to the speaker.
- A custom made built-in battery to power the amplification circuit.
- A magnetic sensor to program device parameters and to remotely control user settings (On/Off/Sleep/Volume).
- Mechanical components to protect the device from cerumen.
- A removal loop to allow the user and/or professional to remove the device.
- Seals that allow the device to fit comfortably in the ear canal
Accessories available for Lyric2:
- User Remote Control
- Device sizer to determine best device size
- Length sizer to determine insertion depth
- An insertion tool for insertion and removal of device and device sizers
- A dedicated software and programming interface to program the device with customer specific settings
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics of the Lyric Hearing Aid have been evaluated in accordance with ANSI S3.22:2009, "Specification of Hearing Aid Characteristics." The device met all applicable specifications developed by the company in accordance with design input specifications. Additional performance and functional testing, including biocompatibility testing, electrical safety, and electromagnetic compatibility testing, has confirmed the equivalent performance of the modified Lyric compared to the cleared Lyric. Post-market clinical testing also confirmed the comparable performance of the Lyric2 to the cleared device. These data included an assessment for appropriate device sizing, as well as clinical assessments of gain, speech understanding, and sound quality of the study device, length of device wear, patient ratings of comfort, assessment of the proportion of the otherwise eligible population who meet the sizing parameters of the study device, post-removal health of the ear, and usability evaluations by patients and audiologist. The clinical assessments performed demonstrated the comparable safety and efficacy of the Lyric2.
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
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.
0
KI30790
510(k) SUMMARY
Phonak's Lyric2
JUN 2 7 2013
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Phonak LLC 4520 Weaver Pkwy Warrenville, IL 60555
Phone: 630-821-5058 Facsimile: 630-393-7400
Contact Person: Laura Eilman
Date Prepared: May 29, 2013
Name of Device and Name/Address of Sponsor:
Lyric2
Phonak LLC 4520 Weaver Pkwy Warrenville, IL 60555
Common or Usual Name: Lyric or Lyric2
Classification Name: Hearing Aid, air conduction
Predicate Devices
| | MANUFACTURER'S NAME | DEVICE'S TRADE
NAME | 510(K) NUMBER |
|---|-----------------------|------------------------|---------------|
| 1 | Insound Medical, Inc. | Insound XT Series | K021867 |
| 2 | Insound Medical, Inc. | Lyric Hearing Aid | K081136 |
Intended Use / Indications for Use
The Lyric 2 hearing aid is a disposable, extended-wear air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal the hearing aid is discarded.
1
Technological Characteristics
Lyric2 is a disposable, programmable, deep-canal, extended-wear, air conduction hearing device, It uses an analog, digitally programmable WDRC ("Wide Dynamic Range Compression") circuit with very low power consumption. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The amplification characteristics are contained in digitally programmable memory, and adjustment of device parameters is achieved through the proprietary Fitting System and Software.
The Lyric2 consists of:
- A programmable application specific integrated circuit ("ASIC") for analog signal processing. . An analog microphone receives sound waves that will be amplified and transmitted to the speaker.
- A custom made built-in battery to power the amplification circuit. .
- A magnetic sensor to program device parameters and to remotely control user settings � (On/Off/Sleep/Volume).
- Mechanical components to protect the device from cerumen. .
- A removal loop to allow the user and/or professional to remove the device. .
- . Seals that allow the device to fit comfortably in the ear canal
Accessories available for Lyric2:
- User Remote Control
- . Device sizer to determine best device size
- Length sizer to determine insertion depth .
- . An insertion tool for insertion and removal of device and device sizers
- A dedicated software and programming interface to program the device with customer · ● specific settings
Performance Data
The performance characteristics of the Lyric Hearing Aid have been evaluated in accordance with ANSI S3.22:2009, "Specification of Hearing Aid Characteristics." The device met all applicable specifications developed by the company in accordance with design input specifications. Additional performance and functional testing, including biocompatibility testing, electrical safety, and electromagnetic compatibility testing, has confirmed the equivalent performance of the modified Lyric compared to the cleared Lyric. Post-market clinical testing also confirmed the comparable performance of the Lyric2 to the cleared device. These data included an assessment for appropriate device sizing, as well as clinical assessments of gain, speech understanding, and sound quality of the study device, length of device wear, patient ratings of comfort, assessment of the proportion of the otherwise eligible population who meet the sizing parameters of the study device, post-removal health of the ear, and usability evaluations by patients and audiologist. The clinical assessments performed demonstrated the comparable safety and efficacy of the Lyric2.
Substantial Equivalence
The Lyric2 has the same general intended use and same indications, similar technological characteristics, and same principles of operation as the cleared Lyric. The minor differences in the
2
Lyric2's technological characteristics do not raise new questions of safety or effectiveness. Bench and clinical testing demonstrates that the Lyric2 is as safe and effective as the cleared Lyric. Thus, the Lyric2 is substantially equivalent to its predicate device.
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
June 27, 2013
Phonak LLC % John. J. Smith, MD, JD Regulatory Counsel Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004
Rc: K130790
Trade/Device Name: Lyric 2 Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing aid, air-conduction Regulatory Class: Class I Product Code: ESD Dated: May 29, 2013 Received: May 29, 2013
Dear Dr. Smith:
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 cnactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r heast be actised and i Drivination 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Cemer - WO66-G609 Silver Spring, MD 20993-0002
4
Page 2 - Dr. John J. Smith
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric AMann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
K130790 510(k) Number (if known):
Device Name: Lyric2
Indications for Use:
The hearing aid is a disposable, extended-wear air conduction hearing aid, designed to be used and wom by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal the hearing aid is discarded.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sageev George -S 2013.06.21 14:12:21 -04'00'
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