(141 days)
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.
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.
The provided text describes the Tinnitus SoundSupport device and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance data. The device's performance is primarily assessed through compliance with relevant standards and comparison to existing legally marketed devices.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for clinical performance. Instead, performance is evaluated through compliance with various standards and by demonstrating substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, indicating that the device "functioned as intended and the performance observed was as expected" in relation to these standards.
| Acceptance Criteria Category | Specific Standards/Criterion | Reported Device Performance |
|---|---|---|
| Software Functionality | IEC 62304 (Medical device software - Software life-cycle processes) | "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... In all instances, Oticon's Tinnitus SoundSupport functioned as intended and the performance observed was as expected." |
| Underlying Hearing Instrument Functionality | ANSI C63.19-2007 (Compatibility Wireless Communications Devices and Hearing Aids) | "In all instances, the 510(k)-exempt hearing instruments functioned as intended and the performance was as expected." |
| IEC 60118-13 (Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC)) | (Same as above) | |
| 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) | (Same as above) | |
| IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | (Same as above) | |
| ETSI 301 489-3 (Electromagnetic compatibility and Radio spectrum Matters (ERM); EMC standard for radio equipment and services; Part 3: Specific conditions for Short-Range Devices (SRD)) | (Same as above) | |
| 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) | (Same as above) | |
| 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) | (Same as above) | |
| ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | (Same as above) | |
| Safety and Effectiveness | Substantial Equivalence to Predicate Devices (K110932 - GnResound Tinnitus Sound Generator, K123450 - Phonak Tinnitus Balance Software) | "Oticon's Tinnitus SoundSupport is as safe and effective as GnResound's Tinnitus Sound Generator (K110932) and Phonak's Tinnitus Balance Software (K123450)." Minor technological differences do not present any new issues of safety or effectiveness. |
| OSHA Compliance (Output Limitation) | Occupational Safety and Health Administration (OSHA) controls | "Compliance with OSHA controls is achieved through (1) output limitation and (2) professional labeling and (3) patient labeling." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical performance study with a "test set" in the sense of patient data. The performance evaluations mentioned are related to software verification and validation, as well as electrical, EMC, and biocompatibility standards for the device's components. There is no mention of a sample size of patient data, nor its provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Since there is no "test set" of patient data with a ground truth established by experts, this information is not applicable and not provided in the document.
4. Adjudication Method for the Test Set
As there is no clinical "test set" of patient data, an adjudication method is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is a "Tinnitus Masker" and a software module integrated into hearing aids, not an AI-assisted diagnostic or interpretative tool for human readers.
6. Standalone (Algorithm Only) Performance Study
The document describes the performance of the embedded software module and the underlying hearing instruments as meeting relevant standards and functioning as intended. This can be considered a standalone performance evaluation in the sense that the software/device's technical performance was verified. However, it's not a clinical standalone study to assess its effectiveness in relieving tinnitus in patients independent of a human provider's intervention (which is explicitly required as part of a tinnitus management program).
7. Type of Ground Truth Used
For the software and hardware evaluations, the "ground truth" would be the specifications and requirements defined by the relevant standards (IEC 62304, ANSI C63.19-2007, IEC 60118-13, IEC 60601-1-2, IEC 60601-1, ETSI standards, FCC regulations, ISO 10993-1). The device's functionality was compared against these technical specifications.
For the substantial equivalence claim, the "ground truth" is established by comparing the device's indications for use, technological characteristics, and principles of operation to those of the legally marketed predicate devices, with the conclusion that "minor technological differences do not present any new issues of safety or effectiveness."
8. Sample Size for the Training Set
The document does not describe a machine learning algorithm that requires a "training set" of data. The device is a sound generator designed for tinnitus relief, and its functionality is based on established acoustic principles and software engineering, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a machine learning algorithm, this question is not applicable.
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V133308 510(k) SUMMARY
Tinnitus SoundSupport
| Submitter: | Oticon A/SKongebakken 9DK-2765 SmorumDenmarkPhone: +45 3917 7100Fax: +45 3927 7900 | |
|---|---|---|
| Contact Person: | Søren Juel WittOticon A/SKongebakken 9DK-2765 SmorumDenmarkMobile: +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: | K110932K123450 | Tinnitus Sound Generator, GnResoundTinnitus 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
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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.
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| Standards No. | Standards Title |
|---|---|
| ANSI C63.19-2007 | American National Standard Methods of Measurement ofCompatibility between Wireless Communications Devices andHearing Aids |
| IEC 60118-13 | Electroacoustics - Hearing aids - Part 13: Electromagneticcompatibility (EMC) |
| IEC 60601-1-2:2007 +Corrigendum 5/2010 | Medical electrical equipment - Part 1-2: General requirementsfor basic safety and essential performance - Collateralstandard: Electromagnetic compatibility - Requirements andtests |
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance |
| ETSI 301 489-3 | Electromagnetic compatibility and Radio spectrum Matters(ERM); ElectroMagnetic Compatibility (EMC) standard for radioequipment and services; Part 3: Specific conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHzand 40 GHz |
| ETSI 300 330-2 | Electromagnetic compatibility and Radio spectrum Matters(ERM); Short Range Devices (SRD); Radio equipment in thefrequency range 9 kHz to 25 MHz and inductive loop systems inthe frequency range 9 kHz to 30 MHz Part 2: Harmonized ENunder 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 IPart 15- Radio frequency devices- Radio frequency devicesOperation in the band 1.705-10 MHZ. |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluationand 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).
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Comparison table
Oticon A/S.
Tinnitus SoundSupport SUBSTANTIAL EQUIVALENCE CHART
| DeviceManufacturer | 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 isa tool intended togenerate sounds toprovide temporary reliefto patients suffering fromtinnitus as part of atinnitus managementprogram.The target population isthe adult population(>18yrs).Tinnitus SoundSupport istargeted for licensedhearing careprofessionals(audiologists, hearing aidspecialists, orotolaryngologists) whoare familiar with theevaluation and treatmentof tinnitus and hearinglosses. The fitting ofTinnitus SoundSupportmust be done by ahearing care professionalparticipating in a tinnitusmanagement program. | The Tinnitus SoundGenerator Module is atool to generate soundsto be used in a TinnitusManagement Program torelieve patients sufferingfrom tinnitus.The target population isprimarily the adultpopulation over 18 yearsof age. This product mayalso be used withchildren 5 years of age orolder.The Tinnitus SoundGenerator Module istargeted for healthcareprofessionals, which aretreating patientssuffering from tinnitus, aswell as conventionalhearing disorders.The fitting of the TinnitusSound Generator Modulemust be done by ahearing professionalparticipating in a TinnitusManagement Program. | The target group for thePhonak Tinnitus Balancesoftware feature areadult 18 years of age orolder with tinnitus whoalso desire amplification.The Tinnitus Balancesoftware feature andaccompanying hearingaid amplification is fit bya licensed hearinghealthcare professional(audiologist, hearing aidspecialist,otolaryngologist) familiarwith the diagnosis andmanagement of tinnitus.Phonak hearing aidsprovide amplification toaddress sensorineural,conductive, or mixedhearing losses.Depending on thespecific model, Phonakhearing aids cover fittingrange from mild toprofound hearing losses.Before being fit withTinnitus Balance,individuals presentingwith tinnitus should beassessed by a licensedear physician to confirm |
| the source of their | |||
| tinnitus is not due to any | |||
| of the following medical | |||
| conditions: | |||
| Visible congenital or• | |||
| traumatic deformity | |||
| of the ear | |||
| Any active drainage• | |||
| from the ear within | |||
| the previous 90 days | |||
| Sudden hearing loss• | |||
| within the previous | |||
| 90 days | |||
| Acute or chronic• | |||
| dizziness | |||
| Unilateral hearing• | |||
| loss of sudden or | |||
| recent onset within | |||
| the previous 90 days | |||
| Pain or discomfort in• | |||
| the ear | |||
| User population | Adult population (>18yrs) | Primarily adult population(>18yrs), can be used for | Adult population (>18yrs) |
| patients >5yrs | |||
| Schedule of use | All day | All day in all environments | Throughout the day |
| Volume is set by HCP and | Volume is set by HCP and | ||
| can be adjusted by patient, | can be adjusted by patient, | Volume is set by HCP andcan be adjusted by patient, | |
| when in use. Default level | when in use. Default level | when in use. Default level | |
| fixed. | fixed. | based on users hearing | |
| Amplitude modulation and | Amplitude modulation and | level. | |
| steady noise. | steady noise. | Steady noise. | |
| Mechanism | |||
| Sound colors: White, pink | Sound color: White. | Sound colors: White and | |
| and red. | pink. | ||
| Noise can be configured | Noise can be configured | Noise can be configured | |
| from broad band to narrow | from broad band to narrow | from broad band to narrow | |
| band customized to thepatient. | band customized to thepatient. | band customized to thepatient. | |
| Software module embedded | Software module embedded | Software module embedded | |
| TechnologicalCharacteristics | into a digital hearing | into a digital hearing | in a digital hearing aid |
| instrument platform. | instrument platform. | platform. |
510(k) Summary 5
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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.
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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
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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.
§ 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.