SAHALE is a feasibility study designed to assess the safety and effectiveness of the Renova-TT™ Cortical Stimulation System* in treating patients with severe tinnitus. This is an FDA approved clinical research study.

Tinnitus is the sensation of hearing in the absence of external sounds. It can be a relatively benign sound that is heard only occasionally, or it can be a devastating roar 24 hours a day accompanied by hyperacusis (sounds are perceived as very loud) and sound distortion. Varying degrees of subjective tinnitus occur between these extremes. The more severe end of this spectrum can be extremely debilitating, interfering with concentration and sleep.

Northstar has partnered with the Medical College of Wisconsin in Milwaukee WI to complete the SAHALE feasibility study.

The patients included in this study have suffered from subjective unilateral or bilateral tinnitus for more than one year. Patients are screened, imaged, and evaluated in order to enroll patients appropriate for stimulation system implant.

We are not currently enrolling patients for tinnitus.

For more information please contact:
Brian Kopell, MD
206 902-1949
bkopell@northstarneuro.com

*Caution: Investigational device. Limited by Federal (or U.S.) law to investigational use.

**The results of this study have not been shared with the FDA and there can be no definitive claims of safety and effectiveness until the FDA has reviewed and approved the labeling for this product.

Please note: All clinical trials have potential benefits and risks. Any prospective participant must sign an informed consent document in which these risks and benefits are outlined and must be discussed with the physician/institution participating in the clinical research. Once the informed consent is signed the patient may be enrolled in the clinical trial. All information collected about patients is subject to protection under a Federal law known as “HIPAA.” More information about informed consent and the protection of the patient’s personal information is provided to prospective clinical trial participants when they inquire about being involved in the clinical trial.