Neuromod Publishes Results of Second Large Scale Clinical Trial for Tinnitus in Top-Tier Scientific Journal, Shows Greater Improvement of Symptoms - Seite 2

TENT-A2 is the second large-scale clinical trial validating the safety, with
high patient satisfaction and tolerability, of bimodal neuromodulation as a
treatment for tinnitus while also demonstrating greater efficacy in reducing
tinnitus symptoms through optimised treatment regimens compared to the first
large-scale trial.

Bimodal neuromodulation is the stimulation of nerves with two paired stimuli for
therapeutic purposes. The tinnitus treatment device that was used in the study,
known as Lenire and available commercially throughout Europe, was developed by
Neuromod. It consists of wireless (Bluetooth®) headphones that deliver sequences
of audio tones to both ears, combined with electrical stimulation pulses
delivered to the surface of the tongue via 32 electrodes on a proprietary device
trademarked as Tonguetip®. The device's settings can be configured to provide
treatment with different combinations of audio and electrical stimuli.

The timing, intensity and delivery of the stimuli are controlled by an
easy-to-use handheld controller that each participant is trained to use prior to
continuing treatment from home. Before using the treatment for the first time,
the device is configured to the patient's hearing profile and optimised to the
patient's sensitivity level for tongue stimulation.

Similarly to TENT-A1, participants in the TENT-A2 trial were instructed to use
Lenire for 60 minutes each day for 12 weeks. However, after an initial six weeks
of treatment, the timing and delivery of the audio and tongue stimuli were
changed for participants of the TENT-A2 trial for their remaining six weeks of
treatment. In TENT-A1, the stimulation setting remained the same for the full 12
weeks of treatment. This change in treatment regimen resulted in a greater
average reduction in tinnitus symptom severity achieved by treatment compliant
participants[1,4,5].

The study was conducted at the Wellcome Trust-HRB Clinical Research Facility,
St. James's Hospital, Dublin, Ireland with no treatment-related Serious Adverse
Events (SAEs) reported and a high treatment compliance. Out of 191 enrolled
participants, 83.8% used the device at or above the minimum compliance level
over the 12-week treatment period[1].

When treatment was completed, participants returned their devices and were
assessed at three follow-up appointments up to 12 months. 70.3% of the 172
participants who filled out the exit survey said they had benefited from using
the treatment and 87.8% said they would recommend other people with tinnitus to
try the treatment[1].