Instructions for Use

 

Product identification information and data

The device has the following features:

  1. Alleviation of tinnitus ‐ Clinical trial showed an average of 13% reduction in the TFI scores of the active group compared with 2.9% in the control group. All tinnitus sufferers are advised to visit their doctor when they first experience tinnitus for a full check up. This should be done before any tinnitus therapy is used.

  2. Clinically proven ‐ Tested in a randomised controlled trial in 2013/14. Results showed a statistically significant difference in the results of the active group relative to the control group. Trial adhered to CONSORT guidelines.

  3. Non‐invasive ‐ Therapy comprises of a sound file played through headphones, no invasive techniques are employed.

  4. 5 minutes daily use ‐ As tested in the clinical trial. However at medium sound levels (a little above audible for those of normal hearing) the sound file can be listened to for 8 hours continuously without damage. Ref: Noise at Work 2005 UK legislation and Control of Noise at Work Regulations 2007 in Ireland.

  5. Low frequency therapy ‐ Frequencies that form part of the therapy are in the 50 ‐ 120Hz range. This is at the lowest end of the audible range for humans.

  6. Proven to reduce tinnitus within the first month of use ‐ The clinical trial took place over 30 days, at the end point a statistically significant result was observed.

  7. 15% reduction on average in one month ‐ This was the average reduction in the THI scores of the active group on the trial. This relies on patients using the therapy according to guidelines. In addition to this any tinnitus therapy will not work for all so the 15% reduction cannot be guaranteed for all but rather is the average expected when those with excellent benefit and no benefit at all are considered.

  8. Therapy is safe to use beyond one month­‐ Based on the sound levels when the product is used according to instructions there are no potential harmful effects to a person’s hearing.

  9. Therapy can be used by those with hearing loss ‐ 84% of those who took part in the clinical trial had some element of hearing loss and no negative impact was reported. In addition to this there is no logical reason that the therapy would affect those with hearing loss any different to those without. In the case of hearing aid users should consult their audiologist as the comfort of using the therapy will depend both on the headphones and the hearing aids used. The therapy doesn’t rely on the hearing aids being worn so if they cause feedback with the headphones they can be removed for comfort.

Product Delivery

SoundRelief is available for streaming by registered patients from the RestoredHearing website https://www.restoredhearing.com/ or is available as a mobile application running under either the iOS or Android platform(s)

Intended Patients/Users

Sound Relief is destined to be used by patients requiring relief from Tinnitus Sound Relief is destined to be used by patients requiring relief from tinnitus. All such patients should first visit their doctor. RestoredHearing advises that they seek the advice and opinion of a medical professional before using any tinnitus treatment.

Therapy is to be used for a minimum of five minutes a day. Over ear headphones are optimal for use and all volumes should be at a safe level. Volumes should be just above audible when in a quiet environment. For those using phones or MP3 players the volume limiter function should be enabled and adhered to.

In cases of hearing aid use, hearing loss etc. it is advised that patients consult their doctor/audiologist.