Who is the manufacturer of TITAN?

Interacoustics A/S filed the 510(k) submission for TITAN (K121847).

What is the FDA product code for TITAN?

ETY. It is classified under 21 CFR 874.1090 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for TITAN?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TITAN?

Titan with IMP440 (K083861); HEARID WIDEBAND MIDDLE EAR POWER ANALYZER (K053216).

Who can help prepare an FDA 510(k) submission like TITAN?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TITAN

K121847 · Interacoustics A/S · ETY · Nov 29, 2012 · Ear, Nose, Throat

Device Facts

Record ID	K121847
Device Name	TITAN
Applicant	Interacoustics A/S
Product Code	ETY · Ear, Nose, Throat
Decision Date	Nov 29, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1090
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes. The Titan Impedance System measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The Titan Impedance System is suitable for all populations including new-born infants. The Titan Impedance 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.

Device Story

Handheld audiometric device (Titan) with cradle and PC software (Titan Suite/IMP440); used by audiologists/ENTs in clinical settings. Device inserts probe into ear canal; presents calibrated tones/clicks (250-8000Hz); records intensity/phase of reflected sound. Measures acoustic properties: power reflectance, absorption, transmittance, impedance, admittance, and ear canal volume. Includes artifact rejection system to remove noise-contaminated responses. Data transmitted via Bluetooth to PC for analysis. Provides normative data for guidance; displays tympanograms and acoustic reflex measurements. Assists clinicians in diagnosing otologic disorders by evaluating middle ear mobility and functional status.

Clinical Evidence

No clinical data performed. Evidence based on bench testing confirming conformance to international standards (IEC 60645-5/ANSI S3.39) and comparison to predicate devices. Literature cited for normative data and measurement validation.

Technological Characteristics

Handheld diagnostic acoustic impedance instrument; Type 1 (IEC 60645-5/ANSI S3.39). Connectivity: Bluetooth to PC. Power: Battery/Cradle. Stimuli: Chirp/Click. Calibration: IEC 60645-3. Features artifact rejection, normative data overlays, and customizable measurement protocols.

Indications for Use

Indicated for diagnostic hearing evaluations and assessment of middle/outer ear functional condition in all populations, including newborns. Features tympanometry and acoustic reflexes. Contraindicated for users without necessary training/education.

Regulatory Classification

Identification

An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.

Special Controls

*Classification.* Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Predicate Devices

Titan with IMP440 (K083861)
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER (K053216)

Related Devices

K983832 — INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER · Idem (Int'L Dist. of Electronics For Medicine) · Jan 25, 1999
K083861 — TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE · Interacoustics AS · Apr 9, 2009
K162210 — touchTymp · Maico Diagnostics GmbH · Nov 16, 2016
K103760 — TITAN · Interacoustics A/S · May 5, 2011
K151616 — AT235 · Interacoustics A/S · Jul 15, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Titan, IMP440 WBT ### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ### Titan IMP440 WBT Interacoustics A/S Drejervaenget 8 SUBMITTER INFORMATION Company Name Company Address NOV 2-9 2012 Company Phone Company Fax Company e-mail Contact Person Assens DK-5610 Denmark +45 6371 3555 +45 6371 3522 info@interacoustics.com Erik Nielsen. Director, Quality and Regulatory Affairs June. 21 2012 Date Summary Prepared DEVICE IDENTIFICATION Trade Name Common Name Classification Name Product Code Panel Device Class Titan Audiometric equipment. Tester, Auditory Impedance / Evoked response auditory stimulator ETY / GWJ Ear Nose & Throat / Neurology Class II SUBSTANTIAL EQUIVALENCE (TITAN WITH IMP440) Predicate Device Manufacturer 510(k) No. Date Cleared Titan with IMP440 Interacoustics K083861 04/09/2006 SUBSTANTIAL EQUIVALENCE (MIMOSA HEARID) Predicate Device Manufacturer 510(k) No. Date Cleared HEARID WIDEBAND MIDDLE EAR POWER ANALYZER MIMOSA ACOUSTICS, INC K053216 02/10/2006 Image /page/0/Picture/18 description: The image is a logo for Interacoustics. The logo consists of a stylized globe on the left and the word "Interacoustics" in a sans-serif font on the right. A registered trademark symbol is located to the right of the word. The logo is white on a black background. {1}------------------------------------------------ ### Description of device The instrument is audiometric equipment used for measuring aural acoustic impedance and admittance (According to ANSI S3.39). The Titan is a platform with multi functions depending of licensing. The license function for this submission is IMP440 (IMP) for measurement of aural acoustic impedance and admittance. The Titan IMP test is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The IMP test function is already cleared by FDA 510(k) premarket notification K083861 (04/09/2009) The instrument is a diagnostic/clinical instrument (as defined in IEC60645-5), but provides normative data for guidance. Titan consists of a handheld unit named Titan, Titan Cradle (cleared by FDA 510(k) premarket notification K083861) and PC software (Titan Suite/IMP440). The measurements are controlled by the handheld unit. A connection box (shoulder box) enables different types of accessories to be connected to the platform The Titan platform can connect to PC software via a Bluetooth connection. ### Indications for Use The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes. The Titan Impedance System measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The Titan Impedance System is suitable for all populations including new-born infants. The Titan Impedance System is to be used by trained personnel only such as audiologists, ENT surgeons, doctors, 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. Section 05 p. 3 - 11 Image /page/1/Picture/16 description: The image shows the Interacoustics logo. The logo consists of a globe-like icon on the left and the word "Interacoustics" in bold, white letters on a black background. The globe icon has lines running across it, and the word "Interacoustics" is written in a sans-serif font. leading diagnostic solutions {2}------------------------------------------------ ### Technological Characteristics 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) The Titan platform can connect to PC software via a Bluetooth connection. For measuring acoustic properties of the middle ear a probe is placed into the ear canal. The probe presents a calibrated tone or click sound into the ear canal and by recording the intensity and phase of the remaining tone or click in the ear canal it can be derived how much of the sound is absorbed by or transferred into the ear. Most common measures are: - A tympanogram, in which the compliance/absorbance is measured as function of the presented frequencies and pressure in the ear canal; - An acoustic reflex, in which the compliance/absorbance is measured over time as function of the presented frequencies while an acoustic activator is presented that above certain intensity is expected to cause a contraction of the stapedius muscle which in return is expected to cause a change in the compliance/absorbance of the ear. The levels of the tonal and click sounds are to be calibrated in an artificial ear according to peak to peak equivalent signal level principles in IEC 60645-3 Titan with IMP440 WBT is IEC 60645-5/ANSI S3.39, Type 1 (Diagnostic/Clinical) acoustic impedance instrument Section 05 p. 4 - 11 Image /page/2/Picture/11 description: The image shows the Interacoustics logo. The logo consists of a globe-like icon on the left and the word "Interacoustics" in bold, white letters on a black background. A registered trademark symbol is present to the right of the word. leading diagnostic solutions {3}------------------------------------------------ | Description | Titan with IMP440 | Titan with IMP440 WBT | Equivalence | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes. | The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes. The Titan Impedance System measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The Titan Impedance System is suitable for all populations including new-born infants. The Titan Impedance 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. | Same The first paragraph for Titan IMP440 WBT is identical with the previous version of the Titan with IMP440 The addition of subsequent paragraphs is the subject of this 510(k) | | Target population | The devices are suitable for all populations including new-born infants | The devices are suitable for all populations including new-born infants | Same | | Intended user | The devices are to be used by trained personnel only | The devices are to be used by trained personnel only | Same | ## Comparison table for Titan with IMP440 and Titan IMP440 WBT ## Section 05 p. 5 - 11 leading diagnostic solutions Inte {4}------------------------------------------------ | Type | HearID (Predicate) | Titan IMP440 WBT | Comments | |-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Audiometric equipment | Audiometric equipment | Same | | Indications for use | The intended use of the HearID-wbMEPA Middle Ear Power Analyzer is to characterize the middle ear status and to assist in diagnosing middle ear pathologies. The HearID-wbMEPA system measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The devices are suitable for all populations including new-born infants. The devices are to be used by trained personnel only. The HearID system comes in two versions: HearID-b- wbMEPA, and HearID e- wbMEPA, where the difference is the variation of the hardware platform. | The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes. The Titan Impedance System measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The Titan Impedance System is suitable for all populations including new-born infants. The Titan Impedance 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. | Same The first paragraph for Titan IMP440 WBT is identical with the previous version of the Titan with IMP440 Paragraph 2, 3 and 4 for Titan IMP440 WBT are identical with paragraph 2 for the predicate device. The 3rd paragraph for the predicate device is just a listing of variants of devices and has been omitted in the comparison | | Target population | The devices are suitable for all populations including new- born infants | The devices are suitable for all populations including new- born infants | Same | | Intended user | The devices are to be used by trained personnel only. | The devices are to be used by trained personnel only. | Same | | Safety standard | IEC 60601-1 (assumed) | IEC 60601-1 | Same. | | | HearID (Predicate) | Titan IMP440 WBT | Comments | | EMC standard | IEC 60601-1-2 (assumed) | IEC 60601-1-2 | predicate device complies as it at least is CE marked Same. It is assumed that the predicate device complies as it at least is CE marked | | Performance standard | Unknown | IEC 60645-5 / ANSI S3.39 | The Titan IMP440 WBT complies with current state of the art standards. It is unknown if the predicate device complies. | | Frequency Range | 200-6000 Hz | 250-8000Hz | Substantial equivalent Titan system use better transducers so the frequency range can be expanded to 8kHz. We trust that this does not influence the safety or effectiveness of the system | | Intensity Range | 0 - 80dB SPL | 90/94 dB peSPL = 70/74 dB SPL | Substantial equivalent The intensity range is fixed but inside the range as the HeardID. The variable range for HeardID is used for pure tone stimulation and this is not relevant for the Titan WBT. We trust that when the range is inside the predicate device we can declare equivalence for safety and effectiveness. | | Sample time | 0.1 - 10 seconds per point | 21, 5 Hz (Click sample time) | These parameters are not comparable, as the range for the predicate device is for pure tone, and the fixed sample time for Titan is fixed for the broadband click | | Stimuli | Chirp Pure Tone | Chirp (Frequency linearized click) Not relevant | Substantial equivalent | | Artefact rejection | Present | Present | Substantial equivalent. Titan IMP440 WBT has an artefact rejection system | | | HearID (Predicate) | Titan IMP440 WBT | Comments | | | | | to remove responses contaminated with noise or noise artefacts. HearID has equivalent artefact rejection system to minimize noisy measurements. | | Real time display of signal and noise | Present | No real time presentation. | Different. The Titan IMP440 WBT does not have real time display of signal and noise. Titan IMP440 WBT has a real time display of measurement data during acquisition. We trust that such "quality indicator" is irrelevant because the measurement time is so short that an indicator cannot be monitored with any benefit. After the test has finished, accepted and rejected sample ratio can be viewed. | | Normative data | Present | Present | The functionality is substantial equivalent. Both systems have normative data present in the user interface to indicate normal middle ear function. Normative data are acquired individually for each system and is based on different databases. The Titan IMP440 WBT normative data is based on [1], [2]. The HearID norm data is based on other data. | | Reflectance Area Index for enhanced diagnosis | Present | Present | Substantial equivalent. Titan IMP440 WBT uses a shaded area indicating normative region in either 10/90 percentiles or 5/95 percentiles for evaluating measurement results. Identical with normative data above | | | HearID (Predicate) | Titan IMP440 WBT | Comments | | measurement protocols. | Present | Present | Users can change the sequence of measurements to have test protocols fit for diagnostic and clinical purposes. | | Customizable display parameters. | Present | Present | Substantial equivalent. The user can change how many and how graphs are presented on the display. Graphs may differ but the intended purpose is the same. | | Otitis media with effusion examples | Present | Present | The functionality is substantial equivalent. For Titan IMP440 WBT these are sketched examples of curve characteristics based on measurements [4] | | Measurements | | | | | Power Reflectance | Present | Present | Substantial equivalent. Power Reflectance is equal to 1 - Power Absorbance. Power absorbance is plotted in Titan IMP440 WBT. Refer to Power Absorbance | | Power Absorbance | Present | Present…