The Titan with TEOAE440 is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Titan with TEOAE440 includes all ages.

Device Description

The instrument is multi platform audiometric equipment used for various testing of middle ear, inner ear and brainstem abnormalities. This submission is only about OAE measurements of otoacoustic emissions in the human inner ear evoked by acoustic probe pulses. (TEOAE in accordance with IEC60645-6:2009)

The Titan also has a measurement function of otoacoustic emissions in the human inner ear evoked by acoustic probe tones (DPOAE). This functionality is already cleared by FDA 510(k) premarket notification K103760 (05/05/2011)

The Titan OAE test generates an acoustic stimulus in the ear canal at a moderate intensity level. The stimulus vibrates a thin membrane in the cochlear, and activates the outer hair cells located on the membrane. This activation is propagated back through the middle ear as sound into the ear canal. Microphone(s) detects OAErelated sound. Principles are identical for both tone and pulse stimuli.

The instrument has screening and diagnostic functionality of TEOAE (according to IEC 60645-6), which is license dependent. For screening purpose a protocol with Pass-Refer criteria can be set up by the user.

Titan consists of a handheld unit named Titan, Titan Cradle and PC software (Titan Suite, Titan modules/ Titan Applications). The measurements are controlled by the handheld unit. A license system makes it possible within each configuration to select which functionality the user wants to be incorporated in the system.

A connection box (shoulder box) enables different types of accessories to be connected to the platform (depending on the module)

For measuring Transient Evoked OtoAcoustic Emissions (TEOAEs) a probe is placed into the ear canal. A stimulus of short duration (broad band click) is presented into the ear (typically with at intensity of 80dB peSPL). Within a normal functioning cochlea the outer hair cells will become active and produce low intensity tones that travel back out of the ear. The emissions that can be recorded appear in the same frequency range and are recorded following each presentation of the transient stimulation. Being able to measure a significant amount of TEOAEs indicates a normal or close to normal outer hair cell function and is mostly used as a screening for hearing impairment. When no TEOAEs are measured, a priori no conclusion can be made and further diagnostics would be recommended.
The instrument meets the requirements from the international standard for OAE measurements IEC 60645-6.

AI/ML Overview

The provided document is a 510(k) Summary for the Interacoustics Titan with TEOAE440, an otoacoustic emission device. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria through clinical trials.

Based on the available information, here's an analysis of the requested points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the way a clinical study report would. Instead, it relies on demonstrating compliance with international standards and substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable by meeting the requirements of IEC 60645-6 and exhibiting similar or improved technical characteristics compared to the predicates.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary from Submission)
Compliance with IEC 60645-6:2009 (OAE measurements)	"The instrument meets the requirements from the international standard for OAE measurements IEC 60645-6."
Functional Equivalence to Predicate Titan with DPOAE440 (K103760)	"Based on the comparison between the two versions of Titan with OAE capability we appraised they are fully substantial equivalent."
Functional Equivalence to Predicate Eclipse with TEOAE25 (K052562)	"we trust that the two devices are substantial equivalence based on the comparison above."
Technical Characteristics similar to or improved over Eclipse with TEOAE25	Frequency Range: Titan TEOAE440: 500 to 5500Hz (vs. Eclipse TEOAE25: 400 to 4000 Hz) - "Both fulfils the requirements from IEC 60645-6" Level: Titan TEOAE440: 30 to 90 dB peSPL (vs. Eclipse TEOAE25: 50 to 90 dB SPL) - "The level range (30-90) is a requirement From IEC60645-6 clause 5.1.4.2 for type 1 instruments" A/D Resolution: Titan TEOAE440: 24 bit (vs. Eclipse TEOAE25: 16 bit) - "The TEOAE440 offers newer technology with higher resolution (24bit)" Artifact Reject: Titan TEOAE440: 0 -> +60 dB SPL or off (vs. Eclipse TEOAE25: +25 -> +55 dB SPL or off) - "The TEOAE440 offers newer technology and has increased the artifact setting range."
Safety and Effectiveness	"trust the device is safe and effective without further clinical tests." (Based on international standards and predicate comparison)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical tests were performed". Therefore, there is no test set, sample size, or data provenance from clinical data to report. The evaluation was based on design verification and validation against international standards and comparison to predicate devices.

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)

Since no clinical tests were performed, there was no test set requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical tests were performed.

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

Not applicable. The device is a diagnostic instrument (OAE device), not an AI-assisted interpretation system for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is an otoacoustic emission device, which is inherently a standalone diagnostic measurement tool. Its "performance" refers to its ability to accurately measure TEOAEs according to physical and audiological standards. The nonclinical tests ("Design verification and validation were performed according to current standards for OAE ... to assure Titan with TEOAE440 meets its performance specifications") serve as the standalone performance evaluation, confirming the device's technical capabilities in measuring OAEs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the nonclinical tests, the "ground truth" was compliance with the technical specifications and requirements outlined in the international standard IEC 60645-6 for otoacoustic emission devices. The principle of the device is based on known physiological responses (outer hair cell function), and its accuracy is validated against established physical and audiological measurement standards, not medical "ground truth" like pathology in a clinical study.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning algorithm requiring a training set in the conventional sense. Its functionality is based on established physical principles and signal processing, not learned patterns from a large dataset.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of medical device submission.

Summary

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Premarket Notification Submission 510(k)

510(K) SUMMARY

JUN 2 0 2013

Titan Titan with TEOAE440

Submitter Information:

Company Name Address

Phone Fax e-mail Contact Person Interacoustics A/S Drejervaenget 8 Assens, DK-5610, Denmark +45 6371 3555 +45 6371 3522 info@interacoustics.com Erik Nielsen, Director, Quality and Regulatory Affairs Marts 21 2013

Class II (According to 21CFR874.1050)

Date Summary Prepared

Device Identification:

Trade Name Common Name Classification Name Product Code Panel Device Class

Predicate Devices:

Substantial Equivalence 1 Predicate Device Manufacturer 510(k) No. Date Cleared

Titan with DPOAE440 Interacoustics K103760 05/05/2011

Otoacoustic emission device

Titan

EWO

Audiometer

Ear Nose & Throat

Substantial Equivalence 2 Predicate Device Manufacturer 510(k) No. Date Cleared

Eclipse with TEOAE25 Interacoustics K052562 12/23/2005

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Device Description

Indications for Use

Intended operator

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.

Image /page/1/Picture/9 description: The image shows the logo for Interacoustics. The logo consists of a stylized globe symbol above the word "interacoustics" in a sans-serif font. The globe symbol is made up of curved lines that form a sphere with horizontal lines running through it. The text is in all lowercase letters and is bolded.

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TechnologicalCharacteristics	Titan consists of a handheld unit named Titan, TitanCradle and PC software (Titan Suite, Titan modules/ TitanApplications). The measurements are controlled by thehandheld unit. A license system makes it possible withineach configuration to select which functionality the userwants to be incorporated in the system.A connection box (shoulder box) enables different types ofaccessories to be connected to the platform (dependingon the module)For measuring Transient Evoked OtoAcoustic Emissions(TEOAEs) a probe is placed into the ear canal. A stimulusof short duration (broad band click) is presented into theear (typically with at intensity of 80dB peSPL). Within anormal functioning cochlea the outer hair cells willbecome active and produce low intensity tones that travelback out of the ear. The emissions that can be recordedappear in the same frequency range and are recordedfollowing each presentation of the transientstimulation. Being able to measure a significant amountof TEOAEs indicates a normal or close to normal outerhair cell function and is mostly used as a screening forhearing impairment. When no TEOAEs are measured, apriori no conclusion can be made and further diagnosticswould be recommended.The instrument meets the requirements from theinternational standard for OAE measurements IEC 60645-6.
Nonclinical tests summary	Design verification and validation were performedaccording to current standards for OAE (otoacousticsemmissions) to assure Titan with TEOAE440 meets itsperformance specifications.
Clinical tests	No clinical tests were performed, but based on thefulfilment of the international standards for OAE, and thecomparison to predicate devices we trust the device issafe and effective without further clinical tests.
Conclusion	We trust that the verification and validation reports andrisk analysis together with the comparisons provided inthis 510(k) supports the conclusion that the Titan WithTEOAE is safe and effective and that is demonstrates thatthe Titan with TEOAE440 is substantially equivalent to themarketed predictive devices.
	510(k) Summary p. 3Interacoustics

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Description	Titan with DPOAE440	Titan with TEOAE440	Equivalence
Type	Audiometer	Audiometer	Same
RegulationNumber	21 CFR 874.1050(otoacoustic emission device)	21 CFR 874.1050(otoacoustic emission device)	Same
ClassificationProduct Code	EWO	EWO	Same
Regulatory Class	Class II	Class II	Same
Indications for use	The Titan with DPOAE440 isintended for use in theaudiologic evaluation anddocumentation of eardisorders using DistortionProduct OtoacousticEmissions.The target population for Titanwith DPOAE440 includes allages.	The Titan with TEOAE440 isintended for use in theaudiologic evaluation anddocumentation of eardisorders using TransientEvoked Otoacoustic Emissions.The target population for Titanwith TEOAE440 includes allages.	DifferentSeediscussionbelow thistableThedifferenceis the subjectof this 510(k)
Target population	The devices are suitable forall populations including new-born infants	The devices are suitable for allpopulations including new-borninfants	Same
Intended user	The Titan System is to beused by trained personnelonly such as audiologists,ENT surgeons, doctors,hearing healthcareprofessionals or personnelwith a similar level ofeducation.	The Titan System is to be usedby trained personnel only suchas audiologists, ENT surgeons,doctors, hearing healthcareprofessionals or personnel witha similar level of education.	Same
Database
	Supported by InteracousticsOtoAccess™ database.	Supported by InteracousticsOtoAccess™ database.	Same
	Operating under NOAH ispossible, using IA NOAHLink.	Operating under NOAH ispossible, using IA NOAHLink.	Same

Comparison table for Titan with TEOAE440 and Titan with DPAOE440

Image /page/3/Picture/4 description: The image shows the word "Interacoustics" in a bold, sans-serif font. Above the word is a symbol that looks like a stylized globe with three horizontal lines running through it. The logo is simple and modern, and the text is clear and easy to read.

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Discussion Titan with TEOAE440 versus Titan with DPOAE440

We have chosen not to compare the physical data (e.g. weight, dimensions and similar technical performance) as the Titan with TEOAE440 is physically and technically identical with previous versions of the Titan unit. There are no mechanical or hardware distinctions.

There are basically two types of evoked otoacoustic emissions: Transient Evoked (TE) and Distortion Product (DP). They both have an identical purpose. Both otoacoustic emission (OAE) tests determine cochlear status, specifically hair cell function used for evaluation of ear disorders. The difference is the technology. DPOAE acoustic signals are generated in the inner ear during stimulation with two pure tones. TEOAE acoustic signals are emitted by the inner ear after stimulation with a stimulus of short duration. TEOAEs seems slightly better identifying hearing loss at 500 and 1000Hz that DPOAEs are better at identifying hearing loss at 4000Hz. TEOAE and DPOAE identify hearing loss with same accuracy at 2000Hz. The purpose of extending the Titan with TEOAE capability is to provide a full range of test opportunity.

Based on the comparison between the two versions of Titan with OAE capability we appraised they are fully substantial equivalent.

Image /page/4/Picture/6 description: The image shows the Interacoustics logo. The logo consists of a stylized globe symbol above the word "interacoustics" in a bold, sans-serif font. The globe symbol is made up of three curved lines that form a sphere with a horizontal line through the middle. The text is in all lowercase letters and is black.

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Premarket Notification Submission 510(k)

Titan, TEOAE440

Comparison table for Titan with TEOAE440 and Eclipse with TEOAE25

Description	Eclipse with TEOAE25	Titan with TEOAE440	Equivalence
Type	Audiometer	Audiometer	Same
RegulationNumber	21 CFR 874.1050(otoacoustic emission device)	21 CFR 874.1050(otoacoustic emission device)	Same
ClassificationProduct Code	EWO	EWO	Same
Regulatory Class	Class II	Class II	Same
Indications for use	The Interacoustics TEOAE25system is intended fordetermining Cochlear functionusing Transient EvokedOtoaccoustic Emission clickstimuli.	The Titan with TEOAE440 isintended for use in theaudiologic evaluation anddocumentation of eardisorders using TransientEvoked OtoacousticEmissions. The targetpopulation for Titan withTEOAE440 includes all ages.	SimilarThe indicationsfor use isintended tocover the sameclinical purposeas TEOAE25,but the wordingis just alignedwith theindications foruse defined forTitan withDPOAE440
Target population	The devices are suitable for allpopulations including new-born infants	The devices are suitable forall populations including new-born infants	Same
Intended user	The Eclipse System is to beused by trained personnel onlysuch as audiologists, ENTsurgeons, doctors, hearinghealthcare professionals orpersonnel with a similar levelof education.	The Titan System is to beused by trained personnelonly such as audiologists,ENT surgeons, doctors,hearing healthcareprofessionals or personnelwith a similar level ofeducation.	Same
Stimulus:
Frequency Range	400 to 4000 Hz	500 to 5500Hz	SimilarBoth fulfils therequirementsfrom IEC 60645-6
Stimuli type	Non-Linear and LinearShort duration signal (Click)According to IEC 60645-3	Non-Linear and LinearShort duration signal (Click)According to IEC 60645-3	Same
Description	Eclipse with TEOAE25	Titan with TEOAE440	Equivalence
Level	50 to 90 dB SPL	30 to 90 dB peSPL	Similar
			The level range(30-90) is arequirementFrom IEC60645-6 clause 5.1.4.2for type 1instruments
Level Step	1 dB SPL	1 dB SPL	Same
Transducer	DedicatedTEOAE25 probe	DedicatedIOW Probe	SimilarBoth arededicatedprobes fordifferent systems
Probe detection	Auto detection	Auto detection	Same
Recording -
A/D Resolution	16 bit	24 bit	Similar
			The TEOAE440offers newertechnology withhigher resolution(24bit)
Artifact Reject	+25 -> +55 dB SPL or off.	0 -> +60 dB SPL or off	Similar
System			The TEOAE440offers newertechnology andhas increasedthe artifactsetting range.
Automatic test withdisplay of PASS-REFER	Yes	Yes	Similar.See discussionbelow

510(k) Summary p. 6

Interaco

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ﺗﺮ

Interacoustı CS

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Discussion Titan with TEOAE440 versus Eclipse TEOAE25

The Titan with TEOAE440 and Eclipse with TEOAE25 share the same otoacoustic emission method. The otoacoustic emissions are emitted from the inner ear after stimulation with a stimulus of short duration. The stimulus is in accordance with the international standard IEC 60645-3 for both instruments. They differ slightly based on the technology. As the Eclipse has older technology the Titan with TEOAE440 has better technical characteristics. This was also concluded though the validation of the Titan with TEOAE440. Beside that we trust that the two devices are substantial equivalence based on the comparison above.

Both instrument types have Automatic test with display of PASS-REFER. The automatic test is in accordance with IEC60645-6 clause 4, clause 5.3.6 and 5.3.8.

Image /page/7/Picture/5 description: The image shows the logo for Interacoustics. The logo consists of a stylized globe above the word "interacoustics" in a bold, sans-serif font. The globe is made up of several curved lines that create the shape of the continents. The text is all in lowercase letters.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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June 20, 2013

Interacoustics A/S c/o Mr. Erik Nielsen Director, Quality and Regulatory Affairs 8 Drejervaenget Assens Denmark, DK-5610

Re: K130795

Trade/Device Name: Titan with TEOAE440 Regulation Number: 21 CFR 874.1050 Regulation Name: Otoacoustic Emissions Device Regulatory Class: Class II Product Code: EWO Dated: March 22, 2013 Received: May 22, 2013

Dear Mr. 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.Fiood..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.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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Page 2 - Mr. Erik Nielsen

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

-Director-

Eric A. Mann -S

for Malvina B. Eydelman, M.D.

Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Submission 510(k)

Indications for Use

Applicant: Interacoustics A/S

510(k) Number (if known): K130795

Device Name: Titan with TEOAE440,

Indications for Use:

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 IF NEEDED)_

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eric A. Mann -S

Page 1 of 1

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leading diagnostic solutio

Regulation Number and Section

§ 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.