Who is the manufacturer of WAVE 2G, SOUL?

Hansaton Akustik GmbH filed the 510(k) submission for WAVE 2G, SOUL (K130937).

What is the FDA product code for WAVE 2G, SOUL?

KLW. It is classified under 21 CFR 874.3400 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for WAVE 2G, SOUL?

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

What are the predicate devices for WAVE 2G, SOUL?

TCI Combi (K003558); TCI (K003559); Custom TCI Combi (K011366); Widexlink in clear series hearing aids (K101699).

Who can help prepare an FDA 510(k) submission like WAVE 2G, SOUL?

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.

WAVE 2G, SOUL

K130937 · Hansaton Akustik GmbH · KLW · Jan 3, 2014 · Ear, Nose, Throat

Device Facts

Record ID	K130937
Device Name	WAVE 2G, SOUL
Applicant	Hansaton Akustik GmbH
Product Code	KLW · Ear, Nose, Throat
Decision Date	Jan 3, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.3400
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

Hansaton WAVE 2G and SOUL are air-conduction broadband noise generators; SOUL includes hearing aid amplification. Available in In-The-Ear (ITE) and Behind-The-Ear (BTE) form factors. Operated by hearing health specialists (audiologists, ENT) for tinnitus habituation and masking therapy. Devices output noise of specific intensity/bandwidth to mask tinnitus; SOUL provides additional amplification for hearing loss. Clinicians program devices to patient needs; patients use devices daily to manage tinnitus symptoms. Benefits include reduced tinnitus perception and improved quality of life through habituation or masking.

Clinical Evidence

Bench testing only. Compliance with IEC 60118 series (electroacoustical characteristics, induction coils, AGC, electrical input, EMC) and ISO 10993 biocompatibility standards. Speech testing performed per Nordic Requirements 7th edition.

Technological Characteristics

Digital circuit; programmable; multiple programs/memories. Available as BTE (X-Mini, Slim) and ITE (Mini Canal, Cymba). Connectivity: SOUL supports wireless communication. Biocompatibility per ISO 10993. Standards: IEC 60118-0, 60118-1, 60118-2, 60118-6, 60118-13.

Indications for Use

Indicated for adults >18 years experiencing tinnitus, with or without hearing loss, requiring tinnitus habituation or masking therapy. Contraindicated for pediatric use.

Regulatory Classification

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.

Special Controls

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.

Predicate Devices

TCI Combi (K003558)
TCI (K003559)
Custom TCI Combi (K011366)
Widexlink in clear series hearing aids (K101699)

Submission Summary (Full Text)

{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 In-the-canal and half shell: 84 dB Broadband noise | n/a | | RMS output characteristics (Hearing aid amplifier) | n/a | (ANSI S3.22- 2003) HF-Average OSPL 90 Mini Canal: | 105 dB HF- Average OSPL 90 (ANSI S3.22-1996) | n/a | ITE: 105 dB HF-Average OSPL 90 (ANSI S3.22- 1996) (110/40/03 matrix) | n/a | | | Hansaton WAVE 2G | Hansaton SOUL | TCI Combi K003558 | TCI K003559 | Custom TCI Combi K011366 | Widexlink in clear series hearing aids K101699 | | | | Slim: 116 dB 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 Page 1 of 1

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