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The Peace N Quiet device is indicated for use in the temporary relief of tinnitus symptoms. The device plays customized sounds to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is for patients who are 18 years or older. This device should only be used with the advice of a physician, audiologist or other healthcare professional.

The Peace N Quiet tinnitus device is software as a medical device implemented as a mobile application for patients suffering from tinnitus. The Peace N Quiet tinnitus mobile app can be downloaded from the Apple Store onto a personal Apple iPhone device facilitates a qualified healthcare professional (HCP). i.e., physician or audiologist, to provide professional counseling or education to the patient. The HCPs can direct and assist patients to self-administer customized treatments using the Peace N Quiet tinnitus device.

Tinearity G1 is intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noise to provide relief for patients with normal hearing in the home healthcare environment. The device is for prescription use only. The target population is adult population over 18 years of age. Tinearity G1 is applied on intact skin at the mastoid bone and transfers sound through bone conduction to the cochlea. Hearing health care professional shall be consulted for diagnosis, fitting of devices, and follow-up care.

The Tinearity G1 device is designed to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. Tinearity G1 comprises of three components: a sound generator, an adapter and a charger. The sound generator is attached to the skin behind the ear by means of the adapter. The sound generator converts white noise into vibrations that are transmitted via the adapter through the skull to the inner ear. The device generates white noise within the frequency span of 700z-10Khz with a maximum output level of 48dB HL. The adapter is a disposable device that serves as a mechanical connector between the sound generator and the user. The adapter is made up of a plastic holder that is compatible with the sound generator and a medical grade tape to be attached to the user's skin behind the ear. The adapter is a single use device and is designed to be removed daily after each treatment. The sound generator uses a re-chargeable battery as power source which is charged with the charger. The Tinearity G1 sound generator and adapter can be used during all times of the day, during sleep as well as during work and spare time.

Tinnitogram™ Signal Generator is a sound generating software used in a Timitus Management Program designed to provide temporary relief for people experiencing timitus symptoms. It is intended primarily for adults over 18 years of ages, but may also be used for children 5 years of age or older. Tinnitogram™ Signal Generator is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that patient listen to the Timitogram™ Signal Generator signal for 30 minutes twice a day at the barely audible level (minimally detectable level).

GOLDENEAR COMPANY's TINNITOGRAM™ SIGNAL GENERATOR is a software as a medical device recommended to use a PC (desktop or laptop computer). TINNITOGRAM™ SIGNAL GENERATOR is fitted to the patient by the healthcare professional. The software enables qualified professional to create customized sounds with specific frequency range for sound therapy/masking. Device type is Stand-alone software as a medical device. The tinnitus masking signal is generated through a pre-process of securing the patient's customized signal. The test to find tinnitus frequencies, the pre-process, is performed automatically and this masking signal is generated at patient's barely audible level.

The SilentCloud in combination with a Tinnitus Management Program is a therapeutic software tool for the treatment of chronic subjective tinnitus for home use. The target population for the Universal Tinnitus Management System are adult tinnitus patients over 18 years. The SilentCloud is intended to provide relief from the disturbance of chronic subjective timitus while using the device. The SlientCloud is fitted and programmed by a qualified healthcare professional familiar with timitus treatment.

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The Multiflex Tinnitus Technology 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. The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology must be done by a hearing professional participating in a Tinnitus Management Program.

Multiflex Tinnitus TechnologyTM (Tinnitus Multiflex) is designed to generate noise that can optionally periodically fluctuate in amplitude and frequency to provide relief for patients suffering from tinnitus. Tinnitus Multiflex is a firmware program code (algorithm) that is embedded as part of the integrated circuit (IC) in the Digital Signal Processing (DSP) stage of a hearing-aid. More specifically, Tinnitus Multiflex is an added branch of code that is separate from the normal existing hearing-aid firmware. As such, hearing-aid operating characteristics (besides tinnitus-stimulus functionalities) are not impacted by the Tinnitus Multiflex branch of code. Tinnitus Multiflex may be deployed across all Starkey hearing-aid models. Tinnitus Multiflex functionalities and parameters are enabled and adjusted by a hearing-care professional utilizing the Starkey proprietary hearing-aid programming software, Inspire. The Tinnitus Multiflex can be manually adjusted to a patient's stimulus needs or automatically adjusted via the new audiogram shaping functionality.

The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily 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 Tinnitus Sound Generator Module must be done during an in-office visit by a hearing professional participating in a Tinnitus Management Program. If deemed feasible by the hearing professional, subsequent fittings of the Tinnitus Sound Generator Module may be performed remotely and in real time while having live communication via live audio, video and chat on the user's dedicated app.

The Tinnitus Sound Generator (TSG) Module is software that provides a means for healthcare professionals to create a hearing instrument solution that provides temporary relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user (EU) can wear this device in all environments. The fitting of the digital device, which contains the TSG Module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient. A mobile medical application (app) is available as an optional device to use with the TSG. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Tinnitus Manager app and is part of the Smart3D app. The Smart3D app also enables a Health Care Professional (HCP) to remotely adjust the TSG settings using a Remote Fine Tuning Feature (RFT). The Support for the RFT feature for the TSG Module can be enabled by the doctor, audiologist or other hearing healthcare professional, at the time of first fitting. Afterwards, the doctor, audiologist or other hearing healthcare professional is able to remotely make adjustments to TSG Module settings. RFT is only enabled when the doctor, audiologist or other hearing healthcare professional finds it feasible, based on an initial in-office assessment of the user and communication with the user, and the parent or legal guardian in cases where the user is a minor. Subsequent to the in-office assessment, the user, or the parent or legal guardian in cases where the user is a minor, is required to accept to receive the adjustments via the TSG portion of the Smart3D app, called the Tinnitus Manager. Compared to the Remote Fine Tuning, available in the predicate device, the subject TSG Module additionally supports Remote Fitting, being used for real time, online adjustments, with live communication with the end user. Support for Remote Fitting is a process where the end user (EU) has a scheduled appointment with the hearing Health Care Professional (HCP) while the EU is at a remote location, like at home. HCP and EU meet via an HCP initiated live audio, live video and chat on the user's Smart3D app, and adjustments can be made to the Hearing Aids per agreement and prescription of the HCP. During this process, the HCP can make multiple adjustments in real time to the Hearing Aids, including TSG, while having live communication with the EU as if they were in the same room. The session is similar to an adjustment session done at the HCP office, but with the EU at a remote location. When the final settings are decided, a fitting data package is generated by the HCP, and the Hearing Aids are updated remotely while having the live session with the EU. Subsequent to the in-office assessment, the user, or the parent or legal guardian in cases where the user is a minor, is required to accept the adjustments. The Remote Fitting is only made available and technically working for follow-up sessions when found feasible by the HCP, and not available for the initial first-time fitting of the Hearing Aids, that has to take place at the HCP office.

The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily 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 Tinnitus Sound Generator module must be done by a hearing professional participating in a Tinnitus Management Program.

The Tinnitus Sound Generator (TSG) Module provides a means for healthcare professionals to create a hearing instrument solution that provides temporary relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user (EU) can wear this device in all environments. The fitting of the digital device, which contains the TSG Module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient. A mobile medical application (app) is available as an optional device to use with the TSG. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Tinnitus Manager app and is part of the Smart3D app. The subject TSG Module has a new feature. i.e., Remote Fine-tuning (RFT) communication software (PC Interface software) that communicates with a healthcare professional's Fitting Software (FSW) via the user's Smart3D app and is part of the general software on the digital signal processor in GN's legally marketed, class II, 510(k) exempt Hearing Aids (Reference Device). The RFT communication software in the Reference device enables the healthcare professional to remotely adjust the Hearing Aid settings for these legally marketed, class II, 510(k) exempt Hearing Aids, including Hearing Aids that are compatible with the predicate TSG Module and the new TSG Module. Similarly, the new TSG Module has a PC Interface Software modification that supports fine tuning of TSG Module settings from a remote location. The new TSG Module's PC Interface Software modification opens a bridge between the general RFT function on the Hearing Aid's digital signal processor and the TSG feature settings, that are also available for adjustments via the user's Smart3D app. Therefore, the RFT communication software part of the general software on the Hearing Aids containing the new TSG Module is also part of new TSG Module device. The Health Care Professional (HCP) can make all of the same changes (Volume/loudness, Pitch/frequency. Nature sounds, and Amplitude modulation) that the user can make. Additionally, the HCP can turn the TSG/tinnitus masker on or off and can set and adjust the Volume Control range and environmental steering sounds. The TSG Volume Control range feature is available only to the HCP. This feature allows the HCP to set a limit on the TSG volume range an EU can adjust. This feature is specifically designed for the safety of the EU, ensuring that an EU cannot increase the TSG volume above a level determined appropriate by the HCP. The system can in no case exceed 100dB SPL for TSG. The TSG Volume Control range has a range of +12dB to -6dB from the TSG fitting by the HCP and can be found in the FSW under the Fitting / Manual Controls / Volume Control Range. For example, if the HCP sets the TSG Volume Control range to +6dB to -6dB, this means an EU cannot set the TSG volume more than 6dB above or below the initial fitting.

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 Tinnitus Sound Generator provides a means for healthcare professionals to create a hearing instrument solution that provides relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user can wear this device in all environments. The fitting of the digital device, which contains the Tinnitus Sound Generator module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient. A mobile medical application (app) is available as an optional device to use with the Tinnitus Sound Generator. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Tinnitus Manager app.

audifon Tinnitus-Module is a tool intended to generate sound as part of a Tinnitus Retraining Therapy (TRT) protocol designed to provide temporary relief for people experiencing tinnitus symptoms. The module in a hearing aid. audifon Tinnitus-Module is intended for adults over 18 years of age. audifon Tinnitus-Module is targeted for licensed hearing care professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of audifon Timitus-Module must be done by a hearing care professional participating in a tinnitus management program.

The above mentioned audifon Tinnitus module is a digital noise generator which was developed to be used in a tinnitus retraining therapy. This product has up to four different programs, which can be programmed in shape and level to fit the individual user's needs. The programming can be done with a standard HI-PRO and the audifon audifit software. Within the software the amplification of the device can be fitted to the individual needs. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It can be housed in a standard In-the-ear instrument housing, in a standard behind-the-ear instrument housing as well as in standard receiver-in-the ear housing.

The TinniLogic Mobile Tinnitus Management Device is indicated for use in the temporary relief of tinnitus symptoms. The device is a player to play customized sounds and display professional counseling or education to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older). This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.

The TinniLogic Mobile Tinnitus Management Device is a sound player which is designed to assist the qualified healthcare professional in delivering customized sound therapies and professional counseling or education to the patient for treatment. The TinniLogic Mobile Tinnitus Management Device provides idiopathic tinnitus sound treatment based upon sound stimulation during sleeping or waking hours. The TinniLogic Mobile Tinnitus Management Device uses amplitude modulated (SAM) tinnitus pitch matched sounds, narrow-band noise centered at the tinnitus frequency. broad-band noise, pure tone, white noise, natural sounds, and combination of these sounds. The subject device consists of a tablet, a specialized headset, a charger and a charger cable.