Are there any legal or ethical issues regarding using hearing aids with a tinnitus manager for patients with normal hearing but have tinnitus, if the amplifier is turned off and only the tinnitus manager is utilized?
Dennis Van Vliet: Legal issues are defined on a state by state basis. The idea of using mild amplification as a method for tinnitus relief, properly applied with objective measures to demonstrate that the wearer won’t be exposed to excessive sound pressure levels, can be defended on the basis of outcomes if the patient expresses that subjective benefit was experienced from the treatment. Similarly, treatment with sound therapy can be defended as long as the treatment is within the scope of practice for the hearing professional in the jurisdiction where the treatment was delivered.
Ethical issues are not legal issues. If a hearing aid, or any therapy device or procedure is recommended following evidence based practice with no offer of guarantee of a cure or success, the treatment may satisfy ethical principles.
Part of the philosophy of developing the Xino tinnitus device was that clinicians may need the flexibility to experiment with amplification and sound generation therapy to see if relief can be achieved with either approach, or a combination. As long as the patient is given a reasonable opportunity to assess the benefit, and make a final decision about continuing with the treatment or not, I cannot see how there would be an ethical problem. Legal issues are again locally defined.
Lindsay Prusick: In order to bring a tinnitus device to market, every manufacturer must go through a rigorous clearance process with the Food and Drug Administration (FDA). The device is only cleared by the FDA if the manufacturer demonstrates that the device will not represent a potential unreasonable risk of injury, specifically in the form of worsening tinnitus and in the form of additional hearing loss due to long term exposure to amplification to the intended user. Starkey developed the Xino tinnitus device for individuals who have either normal or impaired hearing. Therefore, we had to identify any potential risks that the device may pose to a user and provide methods to diminish these risks. To address the risks, the tinnitus stimulus maximum output was limited to a level that a user could listen to up to 16 hours without exceeding generally accepted noise exposure limits, and in the user operation manual we state to the user:
There are some potential concerns associated with the use of any sound generating tinnitus therapy device. Among them are the potential for worsening of tinnitus, a possible change in hearing thresholds, and possible skin irritation at the point of contact with the device.
Multiflex Tinnitus Technology has been designed to minimize these concerns. However, should you experience or notice any of the above conditions you should immediately discontinue use of the device and seek a consultation with a medical, audiology, or other hearing care professional.
Caution: If set to the maximum output level and worn for periods of time exceeding the recommendations below, your exposure to sound energy has the potential to exceed noise exposure limits. You should not use your Starkey hearing device for more than sixteen (16) hours a day if your device is set at the maximum output level, nor should you use yourdevice if your hearing care professional has set the device at levels that exceed your comfort level.
Thank you for your question!