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.

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

AI/ML Overview

The Phonak's Lyric2 is a hearing aid, so the acceptance criteria would revolve around its acoustic performance, safety, and comfort, as well as its functional equivalence to the predicate device.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance	Comments
Acoustic Performance	Compliance 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."	This indicates that all acoustic performance metrics (e.g., gain, frequency response, distortion) were likely within predefined limits, potentially established by either the standard itself or specific design input requirements that align with the standard.
Functional Equivalence	Comparable performance to the cleared Lyric (predicate device) in various clinical assessments.	Confirmed "equivalent performance of the modified Lyric compared to the cleared Lyric." This included assessment for: - Appropriate device sizing - Clinical assessments of gain - Speech understanding - Sound quality - Length of device wear - Patient ratings of comfort - Proportion of eligible population meeting sizing parameters - Post-removal health of the ear - Usability evaluations by patients and audiologists	This is a broad claim of equivalence across multiple functional and clinical aspects. The details of "comparable" would be defined in the study protocol.
Safety	Biocompatibility, electrical safety, and electromagnetic compatibility.	"Biocompatibility testing, electrical safety, and electromagnetic compatibility testing, has confirmed the equivalent performance of the modified Lyric compared to the cleared Lyric."	This indicates the device meets established safety standards and is comparable to the predicate for these aspects.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the specific sample size(s) for the clinical testing. It refers to "clinical testing" and "post-market clinical testing" but doesn't quantify the number of participants.
Data Provenance: The document does not specify the country of origin. It implicitly describes a prospective study ("Post-market clinical testing also confirmed the comparable performance..."). The phrase "Post-market clinical testing" suggests data collected after the original Lyric (predicate device) was on the market, but this specific study was for the Lyric2.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The evaluations involved "patients and audiologists." While audiologists are qualified professionals, the number and specific experience of those involved in establishing "ground truth" or performing assessments are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. Given the nature of the device (hearing aid) and the stated assessments (gain, speech understanding, comfort, etc.), it's more likely that direct measurements and patient/audiologist feedback were collected and potentially aggregated, rather than a consensus-based adjudication of a subjective "ground truth" in the typical sense (e.g., image interpretation).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study, in the typical sense for diagnostic devices, was likely not done. This type of study (comparing human readers with and without AI assistance on specific cases) is relevant for AI algorithms that aid in interpretation or diagnosis. For a hearing aid, the "effectiveness" is measured by direct device performance and patient outcomes, not by how humans interpret findings with or without the device's "AI."
The study did compare the Lyric2 to the predicate Lyric (without AI, as AI in hearing aids was not as prevalent then) across various clinical parameters, but not in an MRMC paradigm comparing human reading performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, performance characteristics of the device itself were evaluated in a standalone manner. "The performance characteristics of the Lyric Hearing Aid have been evaluated in accordance with ANSI S3.22:2009, 'Specification of Hearing Aid Characteristics.'" This standard involves direct measurement of the device's acoustic output and characteristics, independent of a human ear. This represents the "algorithm only" or device-only performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation appears to be a combination of:
- Objective Measurement Standards: The ANSI S3.22:2009 standard provides objective benchmarks for hearing aid characteristics.
- Clinical Assessments/Patient Outcomes: For aspects like gain, speech understanding, sound quality, comfort, and ear health, the "ground truth" would be derived from clinical measurements and patient self-reports, compared against a baseline or a predicate device.
- Expert Observations: Audiologists performed "usability evaluations" and clinical assessments which would form part of the "ground truth" for those specific metrics.

8. The Sample Size for the Training Set

Not applicable / Not specified. This device is a hardware hearing aid with an analog, digitally programmable circuit. While it uses digital programming, it is not an AI/ML algorithm that requires a "training set" in the modern sense of supervised learning for classification or prediction tasks. The "training" here refers to the engineering design, calibration, and parameter setting, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable / Not specified. As explained above, there isn't a "training set" in the AI/ML context for this type of device. The "ground truth" for its design and programming would be based on established audiological science, hearing aid design principles, and engineering specifications.

Summary

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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 TRADENAME	510(K) NUMBER
1	Insound Medical, Inc.	Insound XT Series	K021867
2	Insound Medical, Inc.	Lyric Hearing Aid	K081136

Intended Use / Indications for Use

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Technological Characteristics

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

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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.

and the control control of the control of the control of

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and the comments of the comments of

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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

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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

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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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Regulation Number and Section

§ 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.