Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard audiometric device for measuring otoacoustic emissions and makes no mention of AI or ML technology.

Therapeutic

No
The device is intended for audiologic evaluation and documentation of ear disorders using otoacoustic emissions, which is a diagnostic purpose, not therapeutic.

Diagnostic

Yes

The device clearly states its intention for "audiologic evaluation and documentation of ear disorders" and describes its "diagnostic functionality of TEOAE." It also mentions that "When no TEOAEs are measured, a priori no conclusion can be made and further diagnostics would be recommended," indicating its role in identifying potential issues that require further investigation, which is a characteristic of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Titan system consists of a handheld unit, a cradle, PC software, and a connection box, indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze specimens from the human body. The description clearly states that the device measures otoacoustic emissions in the human inner ear evoked by acoustic stimuli. It's a direct measurement of a physiological response within the body, not an analysis of a biological sample taken from the body.
The intended use is audiologic evaluation. The purpose is to assess the function of the ear, which is a clinical evaluation, not a laboratory test on a specimen.

The device is an audiometric instrument used for in-vivo measurements of ear function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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. The target population for Titan with TEOAE440 includes all ages.

Product codes (comma separated list FDA assigned to the subject device)

EWO

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

ear canal / inner ear

Indicated Patient Age Range

all ages

Intended User / Care Setting

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.

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)

Nonclinical tests summary: Design verification and validation were performed according to current standards for OAE (otoacoustics emmissions) to assure Titan with TEOAE440 meets its performance specifications.

Clinical tests: No clinical tests were performed, but based on the fulfilment of the international standards for OAE, and the comparison to predicate devices we trust the device is safe and effective without further clinical tests.

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.

K103760, K052562

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

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.

Summary

0

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

1

Device Description

Indications for Use

Intended operator

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.

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.

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.

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)

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. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nonclinical tests summary | Design verification and validation were performed
according to current standards for OAE (otoacoustics
emmissions) to assure Titan with TEOAE440 meets its
performance specifications. |
| Clinical tests | No clinical tests were performed, but based on the
fulfilment of the international standards for OAE, and the
comparison to predicate devices we trust the device is
safe and effective without further clinical tests. |
| Conclusion | We trust that the verification and validation reports and
risk analysis together with the comparisons provided in
this 510(k) supports the conclusion that the Titan With
TEOAE is safe and effective and that is demonstrates that
the Titan with TEOAE440 is substantially equivalent to the
marketed predictive devices. |
| | 510(k) Summary p. 3
Interacoustics |

3

Description	Titan with DPOAE440	Titan with TEOAE440	Equivalence
Type	Audiometer	Audiometer	Same
Regulation
Number	21 CFR 874.1050
(otoacoustic emission device)	21 CFR 874.1050
(otoacoustic emission device)	Same
Classification
Product Code	EWO	EWO	Same
Regulatory Class	Class II	Class II	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.
The target population for Titan
with DPOAE440 includes all
ages.	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.	Different
See
discussion
below this
table
The
difference
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 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.	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
Database
	Supported by Interacoustics
OtoAccess™ database.	Supported by Interacoustics
OtoAccess™ database.	Same
	Operating under NOAH is
possible, using IA NOAHLink.	Operating under NOAH is
possible, 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.

4

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.

5

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
Regulation
Number	21 CFR 874.1050
(otoacoustic emission device)	21 CFR 874.1050
(otoacoustic emission device)	Same
Classification
Product Code	EWO	EWO	Same
Regulatory Class	Class II	Class II	Same
Indications for use	The Interacoustics TEOAE25
system is intended for
determining Cochlear function
using Transient Evoked
Otoaccoustic Emission click
stimuli.	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.	Similar
The indications
for use is
intended to
cover the same
clinical purpose
as TEOAE25,
but the wording
is just aligned
with the
indications for
use defined for
Titan with
DPOAE440
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 Eclipse 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 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
Stimulus:
Frequency Range	400 to 4000 Hz	500 to 5500Hz	Similar
Both fulfils the
requirements
from IEC 60645-
6
Stimuli type	Non-Linear and Linear
Short duration signal (Click)
According to IEC 60645-3	Non-Linear and Linear
Short 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 a
requirement
From IEC60645-
6 clause 5.1.4.2
for type 1
instruments
Level Step	1 dB SPL	1 dB SPL	Same
Transducer	Dedicated
TEOAE25 probe	Dedicated
IOW Probe	Similar
Both are
dedicated
probes for
different systems
Probe detection	Auto detection	Auto detection	Same
Recording -
A/D Resolution	16 bit	24 bit	Similar
			The TEOAE440
offers newer
technology with
higher resolution
(24bit)
Artifact Reject	+25 -> +55 dB SPL or off.	0 -> +60 dB SPL or off	Similar
System			The TEOAE440
offers newer
technology and
has increased
the artifact
setting range.
Automatic test with
display of PASS-
REFER	Yes	Yes	Similar.
See discussion
below

510(k) Summary p. 6

Interaco

6

·

ﺗﺮ

.

Interacoustı CS

7

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.

8

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, positioned to the right. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

9

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

10

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:

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.

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

Image /page/10/Picture/15 description: The image shows the logo for Interacoustics. The logo features the company name in a bold, sans-serif font, with the first letter "I" slightly larger than the rest. To the left of the name is a circular graphic with a globe-like design. The logo is set against a black background.

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