(54 days)
Not Found
No
The summary describes a standard audiometric device using established OAE technologies (DPOAE and TEOAE) and does not mention any AI or ML components in its description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is intended for audiologic evaluation and documentation, which is a diagnostic purpose, not therapeutic.
Yes
This device is intended for the "audiologic evaluation and documentation of ear disorders" using OAE technology, which is a diagnostic purpose. It is also described as "audiometric equipment used for assisting of inner ear abnormalities."
No
The device description explicitly states that Lyra features a "hardware unit connecting to a PC installed with IA OAE suite software". This indicates the device includes both hardware and software components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device measures physical responses: The Lyra system measures otoacoustic emissions (OAEs), which are sounds produced by the inner ear in response to auditory stimuli. This is a physical measurement of the ear's function, not an analysis of a biological sample.
- The intended use is audiologic evaluation: The device is intended for "audiologic evaluation and documentation of ear disorders," which falls under the realm of audiology and hearing assessment, not in vitro diagnostics.
Therefore, the Lyra system, as described, is a medical device used for audiological testing, not an IVD.
N/A
Intended Use / Indications for Use
The Lyra with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Lyra with DPOAE includes all ages.
The Lyra with TEOAE is intended for use in the audiologic evaluation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Lyra with TEOAE includes all ages.
The Lyra System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be necessary knowledge and training to understand its use and how results should be interpreted.
Product codes (comma separated list FDA assigned to the subject device)
EWO
Device Description
The device is audiometric equipment used for assisting of inner ear abnormalities. Lyra features a hardware unit connecting to a PC installed with IA OAE suite software designated for use with Lyra. The PC software provides a user interface designed to integrate in the standard Microsoft Windows environment. Lyra can be purchased with various licenses allowing you to perform different hearing screening tests.
Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal.
Transient otoacoustic emissions (TEOAE) technology uses a short duration stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Examination of Ear
Indicated Patient Age Range
all ages, including new-born infants
Intended User / Care Setting
The Lyra System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education.
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)
Summary of Non-Clinical Testing: Design verification and validation were performed according to current standards for OAE to assure the device meets its performance specifications. EMC and Safety was performed in compliance with recognized standards IEC 60601-1 series, Medical Electrical Equipment - General requirements for basic safety and essential performance. The product meets the requirements from the international standard for OAE measurements IEC 60645 series. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in medical Devices." The software for this device was considered as a "minor" level of concern since a malfunction of, or a latent design flaw in, the Software Device could not lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. Internal validation and comparison tests were performed and demonstrate that Lyra fulfil the requirements and is valid for its intended medical purpose.
Summary of Clinical Testing: Not applicable. Not required to establish substantial equivalence.
Key results: The Lyra was tested according to current standards and there were found no significant differences between the devices. The Lyra conforms to the current standards. After analyzing bench testing, safety, EMC, and software validation (with risk analysis) testing we conclude that the Lyra is found to be substantially equivalent to the predicate devices in technological characteristics and indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
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July 15, 2019
Interacoustics A/S Erik Nielsen Director, Regulatory & Compliance Audiometer Alle 1 Middelfart, DK-5500 Dk
Re: K191372
Trade/Device Name: Lyra Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: May 13, 2019 Received: May 22, 2019
Dear Erik Nielsen:
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. 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 located 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.
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 803) for
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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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/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,
for Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191372
Device Name Lyra
Indications for Use (Describe)
The Lyra with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Lyra with DPOAE includes all ages.
The Lyra with TEOAE is intended for use in the audiologic evaluation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Lyra with TEOAE includes all ages.
The Lyra System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be necessary knowledge and training to understand its use and how results should be interpreted.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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FDA 510(k) K191372 Lyra Summary as required by 21 CFR 807.92.
Administrative Information
Submitter: Interacoustics A/S Audiometer Allé 1
5500 Middelfart Denmark Tel: +45 6371 3555 Fax: +45 6371 3522
Contact Person: Erik Nielsen Director of Regulatory Affairs erni@demant.com
Date Summary Prepared: May 13, 2019
Device Identification
Trade Name: Lyra™ Common Name: audiometry, otoacoustic emission device Device Classification Name: Audiometer Device classification: Class II Panel: Ear Nose & Throat Classification Regulation: 874.1050 Product Code: EWO
Primary Predicate Device: Titan™(TEOAE), cleared on 06/20/2013 via K130795
Secondary Predicate Device: Titan™(DPOAE), cleared on 05/05/2011 via K103760
Device Description
The device is audiometric equipment used for assisting of inner ear abnormalities. Lyra features a hardware unit connecting to a PC installed with IA OAE suite software designated for use with Lyra. The PC software provides a user interface designed to integrate in the standard Microsoft Windows environment. Lyra can be purchased with various licenses allowing you to perform different hearing screening tests.
Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal.
Transient otoacoustic emissions (TEOAE) technology uses a short duration stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment.
Device Intended Use / Device indications for use
The Lyra with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Lyra with DPOAE
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includes all ages.
The Lyra with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Lyra with TEOAE includes all ages.
The Lyra System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.
Technological Characteristics
Lyra features a hardware unit connecting to a PC installed with IA OAE suite software designated for use with Lyra. Power to the Lyra is provided from the USB connection to the PC.
A comparison between the new and predicate devices shows that the technological characteristics and indications for use are equivalent. The device employs similar technology to accomplish the same tasks as the predicates. A detailed table is provided below.
| Description | Titan with TEOAE440 (K130795) | Lyra |
|---|---|---|
| Type | Audiometer – Audiometric equipment | Same |
| Regulation Number | 21 CFR 874.1050 | |
| (otoacoustic emission device) | Same | |
| Classification Product Code | EWO | Same |
| Indications for Use | The Titan with TEOAE440 is intended | |
| for use in the audiologic evaluation | ||
| and documentation of ear disorders | ||
| using Transient Evoked Otoacoustic | ||
| Emissions. | Same | |
| Target Population | The devices are suitable for all | |
| populations including new-born | ||
| infants | Same | |
| Intended User | The Titan System is to be used by | |
| trained personnel only such as | ||
| audiologists, ENT surgeons, doctors, | ||
| hearing healthcare professionals or | ||
| personnel with a similar level of | ||
| education. | Same (or used by a trained | |
| technician under the | ||
| supervision of a professional) | ||
| Anatomical Sites | Examination of Ear | Same |
| Safety Standards | IEC 60601-1 | Same |
| Performance Standards | IEC 60645-6 | Same |
| Device Type | Screening and diagnostic | Same |
| System Configuration | Dedicated hardware unit with no | |
| display or controls. OAE probe | ||
| permanently connected to hardware | ||
| unit. Hardware unit operated through | ||
| a connected PC. | Same for clinical use. | |
| (Titan also has possibility for | ||
| handheld use as it also has | ||
| display and controls on | ||
| device) | ||
| TEOAE Stimulus | ||
| Frequency Range | 500 to 5500Hz | Same |
Equivalence Predicate Chart 1 (primary):
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| Stimuli Type | Non-Linear and Linear
Short duration signal
According to IEC 60645-3 | same |
|----------------------------------------------|----------------------------------------------------------------------------|------|
| Level | 30 to 90 dB peSPL | same |
| Level Step | 1 dB SPL | same |
| Transducer | Dedicated OAE Probe | same |
| Probe Detection | Auto detection | same |
| Recording | | |
| A/D Resolution | 24 bit | same |
| Artifact Reject System | 0 -> +60 dB SPL or off | same |
| Automatic test with display
of PASS-REFER | Yes | same |
Equivalence Predicate Chart 2 (secondary):
| Description | Titan With DPOAE440
(K103760) | Lyra |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Type | Audiometer – Audiometric equipment | Same |
| Regulation Number | 21 CFR 874.1050
(otoacoustic emission device) | Same |
| Classification
Product Code | EWO | Same |
| Indications for Use | The Titan with DPOAE440 is intended for use
in the audiologic evaluation and
documentation of ear disorders using
Distortion Product Otoacoustic Emissions. | Same |
| Target Population | The devices are suitable for all populations
including new-born infants | Same |
| Intended User | The Titan System is to be used by trained
personnel only such as audiologists, ENT
surgeons, doctors, hearing healthcare
professionals or personnel with a similar level
of education. | Same (or used by a trained
technician under the supervision
of a professional) |
| Anatomical Sites | Examination of Ear | Same |
| Safety Standards | IEC 60601-1 | Same |
| Performance
Standards | IEC 60645-6 | Same |
| Device Type | Screening and diagnostic | Same |
| System
Configuration | Dedicated hardware unit with no display or
controls. OAE probe permanently connected to
hardware unit. Hardware unit operated
through a connected PC. | Same for clinical use.
(Titan also has possibility for
handheld use as it also has
display and controls on device) |
| DPOAE Stimulus | | |
| Frequency range
(f2) | 500Hz — 10kHz | Same |
| Stimuli Type | 2 pure tones | same |
| Level | 30 dB SPL to 80 dB SPL | Same |
| Level Step | 1 dB SPL | same |
| Transducer | Dedicated OAE Probe | same |
| Probe Detection | Auto detection | same |
| Recording | | |
| A/D Resolution | 24 bit | same |
| Artifact Reject System | 0 -> +60 dB SPL or off | same |
| Automatic test with display of
PASS-REFER | Yes | same |
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Summary of Non-Clinical Testing
Design verification and validation were performed according to current standards for OAE to assure the device meets its performance specifications. EMC and Safety was performed in compliance with recognized standards IEC 60601-1 series, Medical Electrical Equipment - General requirements for basic safety and essential performance. The product meets the requirements from the international standard for OAE measurements IEC 60645 series. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in medical Devices." The software for this device was considered as a "minor" level of concern since a malfunction of, or a latent design flaw in, the Software Device could not lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. Internal validation and comparison tests were performed and demonstrate that Lyra fulfil the requirements and is valid for its intended medical purpose.
Summary of Clinical Testing
Not applicable. Not required to establish substantial equivalence.
Conclusion
We have compared the intended use and performance characteristics with the predicate device. The Lyra was tested according to current standards and there were found no significant differences between the devices.
The Lyra conforms to the current standards. After analyzing bench testing, safety, EMC, and software validation (with risk analysis) testing we conclude that the Lyra is found to be substantially equivalent to the predicate devices in technological characteristics and indications for use.