None listed
Conditions
Brief summary
Determine the effectiveness of the new 3D sound therapy concept relative to existing standard sound therapy for tinnitus treatment Determine the instrument setting preferences and preferences for Resound 3D hearing devices Determine the effectiveness of 3D assessment and tinnitus adaptation counselling versus TRT directive counselling and maskimg at mixing point as prescribed.
Interventions
All subjects will receive a single 1.5 hour counselling session at the beginning of each phase of the trial. Counselling will be conducted at the beginning of the trial and again 8 weeks later, following the 6 week trial of the hearing device and 2 week wash out period. The participants will be divided into two groups with group one receiving counselling based on Tinnitus Adaptation Level therapy (TALT) and the other receiving directive counselling as specified by tinnitus retraining therapy (TRT). Counselling will be individual face to face. The effect of this initial counselling will be evaluated 1 week following counselling, using scales of tinnitus severity (TSNS), and a depression index (HADS). Subjects will then be fitted with binaural prototype GN Resound hearing devices, capable of delivering masking noise in 2D and 3D. Those subjects who received the adaptation level therapy will be fitted with the hearing devices matched to the location of their tinnitus site. Those that received the TRT counselling will have the hearing devices set to deliver sound to both ears set to the mixing point as defined for TRT by Jastreboff. At 5 weeks fitting, measures of tinnitus annoyance will be measured using the TFI, TSNS, THQ, HHI, CGI. This will be followed by a minimum 2 week wash out period. The subjects will then be crossed over so that those who received TRT and 2D masking will now receive and TALT and 3D masking and those who received TALT and 3D will now receive TRT and 2D. Evaluation of the benefit of the devices and counselling will again be made at one week following counselling and 5 weeks post fitting. All the participants will be fited bilaterally with GN Reound open-fit hearing devices at a separate appointment following the assessment and counselling session (irrespective of which group they were in). A modified DSL(I/O) v5.0 will be used as the amplification perscription target and the fitting will be adjusted according to participants comfort and preference. Care, maintenance and use of the hearing devices will be explained to participants during the hearing device fitting session and they will be reccomended to use the devices in a variety of everyday listening situations. Participants will be told to contact the researcher if they require any further assistance before the next follow up, which will be in 2 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
mild-moderate sensorineural hearing loss in the fitting range of the test devices. They will have moderate-severe (minimum score of 25 on the TFI) chronic (duration greater than 6 months) tinnitus with non-center clearly identified localized tinnitus.
Exclusion criteria
Normal hearing, severe hearing loss No or mild tinnitus Hyperacusis Acute tinnitus (< 6 months) Previous users of sound generators or combination devices Undergoing other treatment for tinnitus or anxiety/depression