Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes the device as a noise generator and hearing aid, and the performance studies reference standard hearing aid testing protocols. There is no mention of AI or ML in the intended use, device description, or any other section.

Therapeutic

Yes
The device is described as being "intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and are suitable for tinnitus masking therapy," which are therapeutic applications.

Diagnostic

No

The document states, "Diagnosis and prescription of the tinnitus maskers must be performed by hearing health specialists." This indicates the device is used after a diagnosis, not for diagnosis itself. Its intended use is therapy (tinnitus habituation and masking) and amplification.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Hansaton Tinnitus Maskers are available as 'In The Ear' (ITE) and 'Behind The Ear' (BTE) versions, which are physical hardware components. The performance studies also reference standards for electroacoustical characteristics and biocompatibility, further indicating a hardware 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 tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Function: The Hansaton Tinnitus Maskers are devices that generate sound (noise and/or amplification) and are placed in or behind the ear. They are used for therapeutic purposes (tinnitus habituation and masking therapy) and potentially for hearing amplification.
Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is based on sound generation and delivery.

Therefore, the intended use and function of the Hansaton Tinnitus Maskers clearly fall outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Hansaton Tinnitus Maskers are air conduction broad band noise generators and hearing aids intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and are suitable for tinnitus masking therapy. Optional, the Hansaton SOUL Tinnitus Maskers provide amplification, intended to be used by those individuals who experience tinnitus and desire amplification. Diagnosis and prescription of the tinnitus maskers must be performed by hearing health specialists (e.g., ENT specialists, audiologists, or hearing system professionals) who are experienced in tinnitus management.

The target population is primarily the adult population over 18 years of age. The instruments are not intended for pediatric use.

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

KLW

Device Description

The Hansaton Tinnitus Maskers are provided in two versions; the WAVE 2G, a noise generator intended to output noise for tinnitus habituation therapy and tinnitus masking therapy, and SOUL, a noise generator and hearing aid additionally providing amplification. Both, the WAVE 2G and the SOUL, systems are available as 'In The Ear' (ITE) and 'Behind The Ear' (BTE) versions.

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

primarily the adult population over 18 years of age. The instruments are not intended for pediatric use.

Intended User / Care Setting

hearing health specialists (e.g., ENT specialists, audiologists, or hearing system professionals) who are experienced in tinnitus management.

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)

The Hansaton WAVE 2G and SOUL tinnitus maskers have been developed and tested in accordance with hearing aids specific standard IEC 60118 series.

IEC 60118-0: Hearing aids Measurement of electroacoustical characteristics .
IEC 60118-1: Hearing aids Hearing aids with induction pick-up coil input .
IEC 60118-2: Hearing aids -Hearing aids with automatic gain control circuits .
IEC 60118-6: Hearing aids -Characteristics of electrical input circuits for hearing aids .
IEC 60118-13: Hearing aids -- Electromagnetic compatibility .

All patient contacting materials have been evaluated in terms of biocompatibility in accordance with the ISO 10993 standard series.

Additionally a speech test was performed in accordance with the Nordic Requirements 7th edition appendix A.

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.

K003558, K003559, K011366

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.

K101699

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

ﺮ

510(k) Summary of Safety and Effectiveness

In accordance with the requirements of the Safe Medical Device Act, Hansaton Akustik GmbH herewith submits a Summary of Safety and Effectiveness.

| Submitter Information: | Hansaton Akustik GmbH
Sachsenkamp 5
20097 Hamburg
Germany
Registration Number: 3004597869
Owner/Operator Number: 9042953 |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Mrs. Kathrin Hesebeck
Hansaton Akustik GmbH
Sachsenkamp 5
20097 Hamburg
Phone: +49 40 298 011-146 |
| US Agent (Contact): | Jane A. Flynn
209 Johnson Road
Morris Plains, NJ 07950 USA
Phone: +1 973 290 9866
E-mail: jflynnmpi@aol.com |
| Date Prepared: | January 03, 2014 |
| Device(s) Identification:
Device Trade Name:
Common Name: | WAVE 2G,
SOUL
Tinnitus Maskers |
| Classification of the device:
Device Classification Name:
Product Code:
Device Classification No.:
Panel:
Regulatory Status: | Masker, Tinnitus
KLW
Part 874.3400
Ear Nose & Throat
Class 2 |

1

Device Description:

The Hansaton Tinnitus Maskers are provided in two versions; the WAVE 2G, a noise generator intended to output noise for tinnitus habituation therapy and tinnitus masking therapy, and SOUL, a noise generator and hearing aid additionally providing amplification. Both, the WAVE 2G and the SOUL, systems are available as 'In The Ear' (ITE) and 'Behind The Ear' (BTE) versions.

Intended Use:

The Hansaton Tinnitus Maskers are air conduction broad band noise generators and hearing aids intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and are suitable for tinnitus masking therapy. Optional, the Hansaton SOUL Tinnitus Maskers provide amplification, intended to be used by those individuals who experience tinnitus and desire amplification. Diagnosis and prescription of the tinnitus maskers must be performed by health specialists (e.g., ENT specialists, audiologists, or hearing system professionals) who are experienced in tinnitus management.

The target population is primarily the adult population over 18 years of age. The instruments are not intended for pediatric use.

Predicate devices:

| 1.
Device Trade Name:
Applicant:
510(k) No.: | TCI Combi
Siemens Hearing Instruments
K003558 | | Hansaton
WAVE 2G | Hansaton SOUL | TCI Combi
K003558 | TCI
K003559 | Custom TCI Combi
K011366 | Widexlink in
clear series
hearing aids
K101699 |
|-------------------------------------------------------|------------------------------------------------------------|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| 2.
Device Trade Name:
Applicant:
510(k) No.: | TCI
Siemens Hearing Instruments
K003559 | Intended Use | The Hansaton
Tinnitus
Maskers are air
conduction
broad band
noise generators
and hearing aids
intended to
output noise of
sufficient
intensity and
bandwidth to be
used for tinnitus
habituation
therapy and are
suitable for
tinnitus masking
therapy.
Diagnosis and
prescription of
the tinnitus
maskers must
be performed by
hearing health
specialists (e.g.,
ENT specialists,
audiologists, or
hearing system
professionals)
who are
experienced in
tinnitus
management.
The target
population is
primarily the
adult population
over 18 years of
age. The
instruments are
not intended for
pediatric use. | The Hansaton
Tinnitus Maskers
are air
conduction broad
band noise
generators and
hearing aids
intended to
output noise of
sufficient
intensity and
bandwidth to be
used for tinnitus
habituation
therapy and are
suitable for
tinnitus masking
therapy.
Optional, the
Hansaton SOUL
Tinnitus Maskers
provide
amplification,
intended to be
used by those
individuals who
experience
tinnitus and
desire
amplification.
Diagnosis and
prescription of
the tinnitus
maskers must be
performed by
hearing health
specialists (e.g.,
ENT specialists,
audiologists, or
hearing system
professionals)
who are
experienced in
tinnitus
management.
The target
population is
primarily the
adult population
over 18 years of
age. The
instruments are
not intended for
pediatric use. | Mask tinnitus as
part of tinnitus
management
program
Provide
amplification for
compensation of
hearing loss | Mask tinnitus
as part of
tinnitus
management
program | Mask tinnitus as part
of tinnitus
management
program
Provide amplification
for compensation of
hearing loss | Mask tinnitus as
part of tinnitus
management
program |
| 3.
Device Trade Name:
Applicant:
510(k) No.: | Custom TCI Combi
Siemens Hearing Instruments
K011366 | Target
population | Individuals who
experience
tinnitus. The
target population
is primarily the
adult population
over 18 years of | Individuals who
experience
tinnitus and
desire
amplification.
The target
population is
primarily the | Adults and children
(≥ 5 years) with
tinnitus and
hearing loss that
are participating in
a tinnitus
management | Adults and
children (≥ 5
years) with
tinnitus that are
participating in
a tinnitus
management | Adults and children
(≥ 5 years) with
tinnitus that are
participating in a
tinnitus management
program | Individuals with a
full range of
hearing loss
severity (from
slight (16 to 25 dB
HL) to profound
(90+ dB HL)) and |

য :

WIDEXLINK IN CLEAR SERIES HEARING AIDS Device Trade Name: Applicant: Office Research in Clinical Amplification 510(k) No.: K101699

2

3

| | Hansaton
WAVE 2G | Hansaton SOUL | TCI Combi
K003558 | TCI
K003559 | Custom TCI Combi
K011366 | Widexlink in
clear series
hearing aids
K101699 |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | instruments are
not intended for
pediatric use. | adult population
over 18 years of
age. The
instruments are
not intended for
pediatric use. | | | | configurations. |
| Circuit type | Digital | Digital | Digital | Digital | Digital | Digital |
| Programmable | Yes | Yes | Yes | Yes | Yes | Yes |
| Multiple
programs/
memories | Yes
(except Cymba) | Yes
(except Cymba) | Yes | No | Yes | Yes |
| Available noises | Four | Four | One | Four | One | n/a |
| Volume control | Yes | Yes | Yes | Yes | Yes | Yes |
| Number of
channels | Eight | (G/AGC)
Business: 12/12
Economy:
8/4 | Four | n/a | n/a | n/a |
| Physical
description | Available as
standard behind-
the-ear (X-Mini
and Slim) and
in-the-ear
solutions (Mini
Canal and
Cymba):
Mini Canal is
custom made | Available as
standard behind-
the-ear (X-Mini
and Slim) and in-
the-ear solutions
(Mini Canal and
Cymba);
Mini Canal is
custom made | Standard behind-
the-ear instrument
housing | Standard
behind-the-ear
instrument
housing | Custom product,
available as in-the-
ear, half shell, and
in-the-canal shell
styles | n/a |
| RMS output
characteristics
(Noiser) | Mini Canal
80 dB

Slim
80/90 dB

X-Mini
(S-receiver)
70 dB

X- Mini
(M-receiver)
80 dB | Mini Canal: 75
dB

Slim:
75/85 dB
(Mini tube/
earhook)

X-Mini
(S-receiver):
65 dB

X-Mini
(M-receiver):
75 dB

X-Mini
(P-receiver)
85 dB | 102 dB Broadband
noise | White noise
71 dB SPL

Pink noise
69 dB SPL

Speech noise
69 dB SPL

High-tone
noise
76 dB SPL | ITE:
89 dB
Broadband noise

X-Mini
(S-receiver):
101 dB

X-Mini
(M-receiver):
114 dB

X-Mini
(P-receiver)
116 dB | | | In-the-canal and half
shell:
107 dB
HF-Average OSPL
90 (ANSI S3.22-
1996) (110/35/03
matrix) | |
| Volume control
range | Programmable:
OFF, 8 dB,
16 dB, 32 dB | Programmable:
OFF, 8 dB,
16 dB, 32 dB | Programmable:
OFF, 8 dB, 16 dB,
32 dB | Programmable:
OFF, 8 dB,
16 dB, 32 dB | Programmable:
OFF, 8 dB, 16 dB,
32 dB | n/a |
| Wireless
communication
of pair of
hearing aids or
device
accessories | No | Yes | No | No | No | Yes |

,

4

The Hansaton WAVE 2G and SOUL Tinnitus Maskers are considered substantial equivalent to the Siemens TCI Combi (K003558), Siemens TCI (K003559), Siemens Custom TCI Combi (K011366), and Office Research in Clinical Amplification's WIDEXLINK (K101699). There is no significant difference in intended use or technology.

Summary of performance testing:

The Hansaton WAVE 2G and SOUL tinnitus maskers have been developed and tested in accordance with hearing aids specific standard IEC 60118 series.

IEC 60118-0: Hearing aids Measurement of electroacoustical characteristics .
IEC 60118-1: Hearing aids Hearing aids with induction pick-up coil input .
IEC 60118-2: Hearing aids -Hearing aids with automatic gain control circuits .
IEC 60118-6: Hearing aids -Characteristics of electrical input circuits for hearing aids .
IEC 60118-13: Hearing aids -- Electromagnetic compatibility .

All patient contacting materials have been evaluated in terms of biocompatibility in accordance with the ISO 10993 standard series.

Additionally a speech test was performed in accordance with the Nordic Requirements 7th edition appendix A.

5

Conclusion:

Hansaton Akustik GmbH believes that the Hansaton Tinnitus Maskers WAVE 2G and SOUL are substantially equivalent to the currently legally marketed devices. They do not introduce new indications for use, have the same technological characteristics and do not introduce new potential hazards or safety risks.

6

DEPARTMENT OF HEALTH & HUMAN SERVICES

N

Public Health Service

DEPARTMENT OF HEALTH & HUMAN SER

January 3, 2014

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Hansaton Akustik GmbH c/o Mr. Nick Burmester Regulatory Affairs & Project Manager, Prosystem AG Beim Strohhause 17 Hamburg, Germany 20097

Re: K130937

Trade/Device Name: WAVE 2G, SOUL Regulation Number: 21 CFR 874.3400 Regulation Name: Tinnitus Masker Regulatory Class: Class II Product Code: KLW Dated: November 18, 2013 Received: December 2, 2013

Dear Mr. Burmester:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

7

Page 2 - Mr. Nick Burmester

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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,

Bradley S. Cunningham -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

8

Indications for Use

510(k) number (if known): K130937

Device Name:

WAVE 2G, SOUL Tinnitus Masker

Indications for Use:

The Hansaton Tinnitus Maskers are air conduction broad band noise generators and hearing aids intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and are suitable for tinnitus masking therapy. Optional, the Hansaton SOUL Tinnitus Maskers provide amplification, intended to be used by those individuals who experience tinnitus and desire amplification. Diagnosis and prescription of the tinnitus maskers must be performed by hearing health specialists (e.g., ENT specialists, audiologists, or hearing system professionals) who are experienced in tinnitus management.

The target population is primarily the adult population over 18 years of age. The instruments are not intended for pediatric use.

Prescription Use x (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)

Srinivas Nandkumar -S

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