(17 days)
The Lyric 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.
The Lyric Hearing Aid amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Lyric Hearing Aid:
The provided document, a 510(k) summary for the Lyric Hearing Aid, is quite limited in the type of information typically found in a detailed performance study report. It primarily focuses on establishing substantial equivalence to predicate devices and states that the device meets internal specifications.
Here's an attempt to extract the requested information, with notes on what is not available in the given text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| General Category: Performance Characteristics | |
| Adherence to ANSI S3.22-2003 "Specification of Hearing Aid Characteristics" | "The performance characteristics of the Lyric Hearing Aid have been evaluated in accordance with ANSI S3.22-2003, 'Specification of Hearing Aid Characteristics.'" |
| Meeting applicable specifications developed by Insound Medical (design input specifications) | "The devices met all applicable specifications developed by Insound Medical in accordance with design input specifications." |
| Specific Criteria (Not explicitly stated in the document) | (No specific numerical or analytical criteria are provided, only a general statement of compliance.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "The devices met all applicable specifications," but does not provide details on how many devices were tested or how many users were involved in any performance evaluations.
- Data Provenance: Not specified. It's unclear if the testing was done internally at Insound Medical, by a third party, or if it involved human subjects. The type of study (retrospective or prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable or not specified. This type of information is typically relevant for studies using expert assessment as a ground truth, often clinical trials or image interpretation studies. For a hearing aid, performance is often measured objectively against standards.
- Qualifications of Experts: Not applicable or not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable or not specified. Adjudication methods are typically used when multiple experts are determining a ground truth for qualitative assessments. The performance evaluation here appears to refer to objective measurements against a standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant to this submission. The device is a hearing aid.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly. The performance evaluation against ANSI S3.22-2003 and Insound Medical's design specifications would be considered standalone performance testing of the device itself, separate from its use by an individual. However, the exact methodology is not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for this device's performance is based on objective measurements against established engineering standards (ANSI S3.22-2003) and the manufacturer's own design input specifications. It is not based on expert consensus, pathology, or patient outcomes in the sense of a clinical trial proving efficacy for a disease. The efficacy of hearing aids in general for hearing loss is well-established, and this submission focuses on the device meeting performance requirements.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a hardware product that amplifies sound; it does not involve machine learning algorithms that require a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML algorithm.
Summary of Limitations in the Provided Document:
The provided 510(k) summary is very concise and primarily aims to establish substantial equivalence. It does not contain the detailed performance study information (e.g., number of subjects, detailed methodology, specific quantitative results) that would typically be found in a full study report or a more comprehensive technical summary for a device with complex clinical endpoints or AI components. The performance data section is brief, stating compliance with an industry standard and internal specifications, without elaborating on the specific tests, results, or conditions.
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Ko8//36
510(K) Summary
MAY -8 2008
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).
Contact Person: Susan Whichard (VP of Marketing) Insound Medical, Inc. 39660 Eureka Drive Newark, CA 94560 USA Telephone: (510) 792-4000, ext 450 Fax: (510) 792-4050
Reason for 510(k) Submission: Change in Indications for Use Device Trade Name: Lyric Device Classification Name: Hearing Aid, Air Conduction: 77 ESD; 21 CFR 874.3300 FDA Establishment Registration Number: 3003793405 Owner / Operator Number: 9051571
Legally Marketed Devices to Which Equivalence is Claimed:
The legally marketed predicate devices to which equivalence is claimed are:
- . The Songbird Disposable Hearing Aid, legally marketing in 2000, after the exemption of hearing aids from 510(k) Notification, effective February 19, 1998.
- The Decibel Articulate G1-P24-MS (K964603), determined to be substantially . equivalent to a pre-enactment device on December 6, 1996. This device was marketed under the name inTune®
- . The Philips XP Series (K921725), determined to be substantially equivalent to a pre-enactment device on August 11, 1992.
- . Insound Medical Lyric, (K021867) determined to be substantially equivalent to K964603, K921725 and a pre-enactment device on November 19, 2002.
Device Description: The Lyric Hearing Aid amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.
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Indications for Use: The Lyric 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.
Descriptive Summary of Technological Characteristics and Those of Predicate
Devices: The Lyric Hearing Aid is an air-conduction programmable hearing aid with a deep canal fitting. The hearing aid's receiver is located around the second bend, transmitting sound to the tympanic membrane. These characteristics are similar to the Philips XP series. Amplification characteristics are contained in digitally programmable memory delivered through programming, as with the Decibel Articulate Hearing Aid. The Lyric Hearing Aid is fit to the user with integrated soft retaining seals, like the Songbird Disposable Hearing Aid. Like both the Decibel and Songbird Hearing Aid, the size of the soft retaining seals is selected from a stock of available sizes. The custom battery of the Lyric Hearing Aid is discarded when the battery is depleted. Those characteristics are similar to the Songbird Disposable Hearing Aid.
Performance Data: The performance characteristics of the Lyric Hearing Aid have been evaluated in accordance with ANSI S3.22-2003, "Specification of Hearing Aid Characteristics." The devices met all applicable specifications developed by Insound Medical in accordance with design input specifications.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 8 2008
InSound Medical, Inc. c/o Ms. Susan Whichard, VP Marketing 39660 Eureka Drive Newark. CA 94560
Re: K081136 Trade/Device Name: Lyric Hearing Aid Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class I (Exempt) Product Code: ESD Dated: April 10, 2008 Received: April 21, 2008
Dear Ms. Whichard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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); 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Egorlino, mrd
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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K081136
Indications for Use
510(k) Number: K081136
Device Name: _Lyric
Indications For Use:
The 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 via air conduction. The hearing aid is placed in the ear canal y an appropriately trained ENT Physician, Audiologist or I-learing Aid Dispenser and can remain the ear canal for up to 4 months or until the battery is depleted. Upon device removal the hearing aid is discarded.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
510(k) Number K084136
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§ 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.