Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a software module that generates sounds based on pre-defined noise types and filters, with manual controls for volume and level steering. There is no mention of algorithms that learn or adapt from data.

Therapeutic

Yes
The device is described as "a tool intended to generate sounds to provide temporary relief to patients suffering from tinnitus as part of a tinnitus management program," which indicates a therapeutic purpose.

Diagnostic

No
Explanation: The device is intended to generate sounds for temporary relief of tinnitus, not to diagnose it. Its purpose is to provide therapy as part of a management program.

SaMD (Software as a Medical Device)

No

The device is described as a "software module added to the company's class II, 510(k)-exempt wireless air conduction hearing instruments". This indicates that the software is an addition to existing hardware (hearing instruments), not a standalone software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The Tinnitus SoundSupport device generates sounds to provide temporary relief from tinnitus. It does not involve the collection or analysis of any biological specimens from the patient.
Intended Use: The intended use is to provide temporary relief from tinnitus as part of a management program, not to diagnose or analyze a biological sample.
Device Description: The device is a software module added to hearing instruments and is fitted externally to the patient's ear.

Therefore, the function and intended use of the Tinnitus SoundSupport device clearly fall outside the scope of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief to patients suffering from tinnitus as part of a tinnitus management program.

The target population is the adult population (>18yrs).

Tinnitus SoundSupport is targeted for licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.

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

KLW

Device Description

Oticon's Tinnitus SoundSupport consists of a software module added to the company's class II, 510(k)-exempt wireless air conduction hearing instruments legally marketed under 21 C.F.R. 874.3305. Tinnitus SoundSupport is fitted to the patient by the Hearing Care Professional using Oticon fitting software. Tinnitus SoundSupport provides the option of relief sounds based on white, pink or red noise. The relief sounds can be limited in frequency by high pass or low pass filters. Tinnitus SoundSupport also provides the option of amplitude modulation, a volume control and automatic level steering. The design of Tinnitus SoundSupport is based on the controls of the Occupational Safety and Health Administration (OSHA). Compliance with OSHA controls is achieved through (1) output limitation and (2) professional labeling and (3) patient labeling. Tinnitus SoundSupport must be used as part of a tinnitus management program.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

The target population is the adult population (>18yrs).

Intended User / Care Setting

Tinnitus SoundSupport is targeted for licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.

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)

Oticon's Tinnitus SoundSupport embedded software module and the Tinnitus tool in the fitting software has been verified and validated according to relevant standard for medical device software (Figure 7-1). In all instances, Oticon's Tinnitus SoundSupport functioned as intended and the performance observed was as expected.

The underlying class II, 510(k)-exempt wireless air conduction hearing instruments marketed legally by Oticon under 21 C.F.R. 874.3305 has been evaluated according to relevant standards. This includes evaluation in accordance with standards relating to EMC and electrical safety as well as biocompatibility (Figure 7-2). In all instances, the 510(k)-exempt hearing instruments functioned as intended and the performance was as expected.

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.

K110932, K123450

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

§ 874.3400 Tinnitus masker.

(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.

Summary

0

V133308 510(k) SUMMARY

Tinnitus SoundSupport

| Submitter: | Oticon A/S
Kongebakken 9
DK-2765 Smorum
Denmark
Phone: +45 3917 7100
Fax: +45 3927 7900 | |
|----------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Contact Person: | Søren Juel Witt
Oticon A/S
Kongebakken 9
DK-2765 Smorum
Denmark
Mobile: +45 3030 2247 | |
| Date Prepared: | 25. October 2013 | |
| Device Name: | Tinnitus SoundSupport | |
| Device Class: | Class II | |
| Classification Name: | Tinnitus Masker | |
| Classification Regulation: | 21 C.F.R. §874.3400 | |
| Product Code: | KLW | |
| Predicate Devices: | K110932
K123450 | Tinnitus Sound Generator, GnResound
Tinnitus Balance Software, Phonak |

Intended Use / Indications for Use

Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief to patients suffering from tinnitus as part of a tinnitus management program.

The target population is the adult population (>18yrs).

Tinnitus SoundSupport is targeted for licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of

1

Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.

Technological Characteristics

. Oticon's Tinnitus SoundSupport consists of a software module added to the company's class II, 510(k)-exempt wireless air conduction hearing instruments legally marketed under 21 C.F.R. 874.3305.
Tinnitus SoundSupport is fitted to the patient by the Hearing Care Professional using Oticon fitting software.

Tinnitus SoundSupport provides the option of relief sounds based on white, pink or red noise. The relief sounds can be limited in frequency by high pass or low pass filters. Tinnitus SoundSupport also provides the option of amplitude modulation, a volume control and automatic level steering.

The design of Tinnitus SoundSupport is based on the controls of the Occupational Safety and Health Administration (OSHA). Compliance with OSHA controls is achieved through (1) output limitation and (2) professional labeling and (3) patient labeling.

Tinnitus SoundSupport must be used as part of a tinnitus management program.

Performance Data

Oticon's Tinnitus SoundSupport embedded software module and the Tinnitus tool in the fitting software has been verified and validated according to relevant standard for medical device software (Figure 7-1). In all instances, Oticon's Tinnitus SoundSupport functioned as intended and the performance observed was as expected.

Standards No.	Standards Title
IEC 62304	Medical device software - Software life-cycle processes
Figure 7-1.

The underlying class II, 510(k)-exempt wireless air conduction hearing instruments marketed legally by Oticon under 21 C.F.R. 874.3305 has been evaluated according to relevant standards. This includes evaluation in accordance with standards relating to EMC and electrical safety as well as biocompatibility (Figure 7-2). In all instances, the 510(k)-exempt hearing instruments functioned as intended and the performance was as expected.

2

Standards No.	Standards Title
ANSI C63.19-2007	American National Standard Methods of Measurement of
Compatibility between Wireless Communications Devices and
Hearing Aids
IEC 60118-13	Electroacoustics - Hearing aids - Part 13: Electromagnetic
compatibility (EMC)
IEC 60601-1-2:2007 +
Corrigendum 5/2010	Medical electrical equipment - Part 1-2: General requirements
for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and
tests
IEC 60601-1	Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
ETSI 301 489-3	Electromagnetic compatibility and Radio spectrum Matters
(ERM); ElectroMagnetic Compatibility (EMC) standard for radio
equipment and services; Part 3: Specific conditions for Short-
Range Devices (SRD) operating on frequencies between 9 kHz
and 40 GHz
ETSI 300 330-2	Electromagnetic compatibility and Radio spectrum Matters
(ERM); Short Range Devices (SRD); Radio equipment in the
frequency range 9 kHz to 25 MHz and inductive loop systems in
the frequency range 9 kHz to 30 MHz Part 2: Harmonized EN
under article 3.2 of the R&TTE Directive
FCC 47 CFR Part 15
§15.109, §15.209, §15.223	Title 47 of the Code of Federal Regulations; Chapter I
Part 15

Radio frequency devices
Radio frequency devices
Operation in the band 1.705-10 MHZ. |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation
and testing within a risk management process |

Figure 7-2.

Substantial equivalence

Oticon's Tinnitus SoundSupport is as safe and effective as GnResound's Tinnitus Sound Generator (K110932) and Phonak's Tinnitus Balance Software (K123450). As shown in the table below, Oticon's Tinnitus SoundSupport, GnResound's Tinnitus Sound Generator (K110932) and Phonak's Tinnitus Balance Software (K123450) have the same intended use and similar indications, technological characteristics and principles of operation. Minor technological differences do not present any new issues of safety or effectiveness. Thus, Oticon's Tinnitus SoundSupport is substantially equivalent to GnResound's Tinnitus Sound Generator (K110932) and Phonak's Tinnitus Balance Software (K123450).

3

Comparison table

Oticon A/S.

Tinnitus SoundSupport SUBSTANTIAL EQUIVALENCE CHART

| Device

Manufacturer	New	Predicate	Predicate
Name	Oticon	GN Resound	Phonak
510(k) #	Tinnitus SoundSupport	Tinnitus Sound Generator	Tinnitus Balance software
		K110932	K123450
Indications for use	Tinnitus SoundSupport is
a tool intended to
generate sounds to
provide temporary relief
to patients suffering from
tinnitus as part of a
tinnitus management
program.

The target population is
the adult population
(>18yrs).

Tinnitus SoundSupport is
targeted for licensed
hearing care
professionals
(audiologists, hearing aid
specialists, or
otolaryngologists) who
are familiar with the
evaluation and treatment
of tinnitus and hearing
losses. The fitting of
Tinnitus SoundSupport
must be done by a
hearing care professional
participating in a tinnitus
management program. | The Tinnitus Sound
Generator Module is a
tool to generate sounds
to be used in a Tinnitus
Management Program to
relieve patients suffering
from tinnitus.

The target population is
primarily the adult
population over 18 years
of age. This product may
also be used with
children 5 years of age or
older.

The Tinnitus Sound
Generator Module is
targeted for healthcare
professionals, which are
treating patients
suffering from tinnitus, as
well as conventional
hearing disorders.

The fitting of the Tinnitus
Sound Generator Module
must be done by a
hearing professional
participating in a Tinnitus
Management Program. | The target group for the
Phonak Tinnitus Balance
software feature are
adult 18 years of age or
older with tinnitus who
also desire amplification.

The Tinnitus Balance
software feature and
accompanying hearing
aid amplification is fit by
a licensed hearing
healthcare professional
(audiologist, hearing aid
specialist,
otolaryngologist) familiar
with the diagnosis and
management of tinnitus.
Phonak hearing aids
provide amplification to
address sensorineural,
conductive, or mixed
hearing losses.
Depending on the
specific model, Phonak
hearing aids cover fitting
range from mild to
profound hearing losses.

510(k) Summary 5

4

5

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to convey the department's mission of protecting and promoting the health and well-being of Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 18, 2014

Oticon A/s c/o Mr. Søren Juel Witt Senior Regulatory Affairs Officer Kongebakken 9 DK-2765 Smørum Denmark

Re: K133308

Trade/Device Name: Tinnitus Soundsupport Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: February 10, 2014 Received: February 14, 2014

Dear Mr. Witt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. "The general controls provisions of the Act include requirements for annual registration. Ilisting 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 cither 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.

6

Page 2 - Mr. Søren Juel Witt

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 (OS) 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/CDRH/CDRHOffices/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.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Indications for Use Statement

5 10(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Tinnitus SoundSupport™

Indications for Use

Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief to patients suffering from tinnitus as part of a tinnitus management program.

The target population is the adult population (>18yrs).

Tinnitus SoundSupport is targeted for licensed hearing care professionals (audiologists, hearing oid specialists, or otoloryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/7/Picture/12 description: The image shows the text "Cherish R. Giusto -S" in a bold, sans-serif font. There is a logo in the background that is difficult to make out. The text is the main focus of the image and is clearly legible. The text appears to be a name, possibly with an initial and a suffix.