***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Objectives : Chronic subjective tinnitus is a prevalent condition that causes significant distress to millions of Americans . Effective tinnitus treatments are urgently needed , but evaluating them is hampered by the lack of st and ardized measures that are vali date d for both intake assessment and evaluation of treatment outcomes . This work was design ed to develop a new self-report question naire , the Tinnitus Functional Index ( TFI ) , that would have documented validity both for scaling the severity and negative impact of tinnitus for use in intake assessment and for measuring treatment-related changes in tinnitus ( responsiveness ) and that would provide comprehensive coverage of multiple tinnitus severity domains . Design : To use preexisting knowledge concerning tinnitus-related problems , an Item Selection Panel ( 17 expert judges ) surveyed the content ( 175 items ) of nine widely used tinnitus question naires . From those items , the Panel identified 13 separate domains of tinnitus distress and selected 70 items most likely to be responsive to treatment effects . Eliminating redundant items while retaining good content validity and adding new items to achieve the recommended minimum of 3 to 4 items per domain yielded 43 items , which were then used for constructing TFI Prototype 1 . Prototype 1 was tested at five clinics . The 326 participants included consecutive patients receiving tinnitus treatment who provided informed consent — constituting a convenience sample .  Construct validity of Prototype 1 as an outcome measure was evaluated by measuring responsiveness of the overall scale and its individual items at 3 and 6 mo follow-up with 65 and 42 participants , respectively . Using a predetermined list of criteria , the 30 best-functioning items were selected for constructing TFI Prototype 2 . Prototype 2 was tested at four clinics with 347 participants , including 155 and 86 who provided 3 and 6 mo follow-up data , respectively . Analyses were the same as for Prototype 1 . Results were used to select the 25 best-functioning items for the final TFI . Results : Both prototypes and the final TFI displayed strong measurement properties , with few missing data , high validity for scaling of tinnitus severity , and good reliability . All TFI versions exhibited the same eight factors characterizing tinnitus severity and negative impact . Responsiveness , evaluated by computing effect sizes for responses at follow-up , was satisfactory in all TFI versions . In the final TFI , Cronbach ’s alpha was 0.97 and test – retest reliability 0.78 . Convergent validity ( r = 0.86 with Tinnitus H and icap Inventory [ THI ] ; r = 0.75 with Visual Analog Scale [ VAS ] ) and discriminant validity ( r = 0.56 with Beck Depression Inventory- Primary Care [ BDI-PC ] ) were good . The final TFI was successful at detecting improvement from the initial clinic visit to 3 mo with moderate to large effect sizes and from initial to 6 mo with large effect sizes . Effect sizes for the TFI were generally larger than those obtained for the VAS and THI . After careful evaluation , a 13-point reduction was considered a preliminary criterion for meaningful reduction in TFI outcome scores . Conclusions : The TFI should be useful in both clinical and research setting s because of its responsiveness to treatment-related change , validity for scaling the overall severity of tinnitus , and comprehensive coverage of multiple domains of tinnitus severity BACKGROUND Up to 21 % of adults will develop tinnitus , which is one of the most distressing and debilitating audiological problems . The absence of medical cures and st and ardised practice can lead to costly and prolonged treatment . We aim ed to assess effectiveness of a stepped-care approach , based on cognitive behaviour therapy , compared with usual care in patients with varying tinnitus severity . METHODS In this r and omised controlled trial , undertaken at the Adelante Department of Audiology and Communication ( Hoensbroek , Netherl and s ) , we enrolled previously untreated Dutch speakers ( aged > 18 years ) who had a primary complaint of tinnitus but no health issues precluding participation . An independent research assistant r and omly allocated patients by use of a computer-generated allocation sequence in a 1:1 ratio , stratified by tinnitus severity and hearing ability , in block sizes of four to receive specialised care of cognitive behaviour therapy with sound-focused tinnitus retraining therapy or usual care . Patients and assessors were masked to treatment assignment . Primary outcomes were health-related quality of life ( assessed by the health utilities index score ) , tinnitus severity ( tinnitus question naire score ) , and tinnitus impairment ( tinnitus h and icap inventory score ) , which were assessed before treatment and at 3 months , 8 months , and 12 months after r and omisation . We used multilevel mixed regression analyses to assess outcomes in the intention-to-treat population . This study is registered with Clinical Trials.gov , number NCT00733044 . FINDINGS Between September , 2007 and January , 2011 , we enrolled and treated 492 ( 66 % ) of 741 screened patients . Compared with 247 patients assigned to usual care , 245 patients assigned  to specialised care  improved in health-related quality of life during a period of 12 months ( between-group difference 0·059 , 95 % CI 0·025 to 0·094 ; effect size of Cohen 's d=0·24 ; p=0·0009 ) , and had decreased tinnitus severity ( -8·062 , -10·829 to -5·295 ; d=0·43 ; p<0·0001 ) and tinnitus impairment ( -7·506 , -10·661 to -4·352 ; d=0·45 ; p<0·0001 ) . Treatment seemed effective irrespective of initial tinnitus severity , and we noted no adverse events in this trial . INTERPRETATION Specialised treatment of tinnitus based on cognitive behaviour therapy could be suitable for widespread implementation for patients with tinnitus of varying severity . FUNDING Netherl and s Organisation for Health Research and Development ( ZonMW ) Hearing aids with an integrated sound generator have been used to enhance the treatment of tinnitus . The main aim of this study was to verify whether the combined use of amplification and sound generator is more effective than conventional amplification alone in reducing  tinnitus annoyance by means of the use of a new hearing aid with an integrated sound generator . A total of 49 patients underwent a blind r and omized clinical trial .  Tinnitus annoyance was measured by Tinnitus H and icap Inventory and numerical scales , and psychoacoustic measures of tinnitus were also performed . The sound generator was set at the lowest intensity capable of providing relief from tinnitus . Results showed that 62.5 % of the patients presented a reduction in tinnitus annoyance in the combined fitting group and in the group with amplification alone , 78 % showed a reduction . This difference between the groups was not statistically significant Objectives : A r and omized cross-over trial in 18 participants tested the hypothesis that nature sounds , with unpredictable temporal characteristics and high valence would yield greater improvement in  tinnitus  than constant , emotionally neutral broadb and noise . Study Design : The primary outcome measure was the Tinnitus Functional Index ( TFI ) . Secondary measures were : loudness and annoyance ratings , loudness level matches , minimum masking levels , positive and negative emotionality , attention reaction and discrimination time , anxiety , depression and stress . Each sound was administered using MP3 players with earbuds for 8 continuous weeks , with a 3 week wash-out period before crossing over to the other treatment sound . Measurements were undertaken for each arm at sound fitting , 4 and 8 weeks after administration . Qualitative interviews were conducted at each of these appointments . Results : From a baseline TFI score of 41.3 , sound therapy result ed in TFI scores at 8 weeks of 35.6 ; broadb and noise result ed in significantly greater reduction ( 8.2 points ) after 8 weeks of sound therapy use than nature sounds ( 3.2 points ) . The positive effect of sound on tinnitus was supported by secondary outcome measures of tinnitus , emotion , attention , and psychological state , but not interviews . Tinnitus loudness level match was higher for BBN at 8 weeks ; while there was little change in loudness level matches for nature sounds . There was no change in minimum masking levels following sound therapy administration . Self-reported preference for one sound over another did not correlate with changes in tinnitus . Conclusions : Modeled under an adaptation level theory framework of tinnitus perception , the results indicate that the introduction of broadb and noise shifts internal adaptation level weighting away from the tinnitus signal , reducing tinnitus magnitude . Nature sounds may modify the affective components of tinnitus via a secondary , residual pathway , but this appears to be less important for sound effectiveness . The different rates of adaptation to broadb and noise and nature sound by the auditory system may explain the different tinnitus loudness level matches . In addition to group effects there also appears to be a great deal of individual variation . A sound therapy framework based on adaptation level theory is proposed that accounts for individual variation in preference and response to sound . Clinical Trial Registration : www.anzctr.org.au , identifier # 12616000742471 Objectives : In this four-site clinical trial , we evaluated whether tinnitus masking ( TM ) and tinnitus retraining therapy ( TRT ) decreased tinnitus severity more than the two control groups : an attention-control group that received tinnitus educational counseling ( and hearing aids if needed ; TED ) , and a 6-month-wait-list control ( WLC ) group . The authors hypothesized that , over the first 6 months of treatment , TM and TRT would decrease tinnitus severity in Veterans relative to TED and WLC , and that TED would decrease tinnitus severity relative to WLC . The authors also hypothesized that , over 18 months of treatment , TM and TRT would decrease tinnitus severity relative to TED . Treatment effectiveness was hypothesized not to be different across the four sites . Design : Across four Veterans affairs medical center sites , N = 148 qualifying Veterans who experienced sufficiently bothersome tinnitus were r and omized into one of the four groups . The 115 Veterans assigned to TM ( n = 42 ) , TRT ( n = 34 ) , and TED ( n = 39 ) were considered immediate-treatment subjects ; they received comparable time and attention from audiologists . The 33 Veterans assigned to WLC were , after 6 months , r and omized to receive delayed treatment in TM , TRT , or TED . Assessment of outcomes took place using the Tinnitus H and icap Inventory ( THI ) at 0 , 3 , 6 , 12 , and 18 months . Results : Results of a repeated measures analysis of variance using an intention-to-treat approach showed that the tinnitus severity of Veterans receiving TM , TRT , and TED significantly decreased ( p < 0.05 ) relative to Veterans in the WLC group at 3 months ( effect sizes = 0.44 , 0.52 , and 0.27 , respectively ) and at 6 months ( effect sizes = 0.52 , 0.56 , and 0.40 , respectively ) . Analyses comparing effectiveness of  TM , TRT  , and  TED over 18 months revealed that the three conditions were not significantly different , but that tinnitus severity in the combined groups significantly decreased ( p < 0.01 ) from baseline to 3 months ( 5.6 THI points ) and from 3 to 6 months ( 3.7 THI points ) . With respect to clinical ly significant change , about half of Veterans who received TM ( 55 % ) , TRT ( 59 % ) , or TED ( 46 % ) showed strong or modest improvement on the THI by 18 months . Without treatment , the WLC group did not show significant change . Treatment effectiveness did not differ by study site . Conclusions : Audiologists who provided interventions to Veterans with bothersome tinnitus in the regular clinic setting were able to significantly reduce tinnitus severity over 18 months using TM , TRT , and TED approaches . These results suggest that TM , TRT , and TED , when implemented as in this trial , will provide effectiveness that is relatively similar by 6 months and beyond BACKGROUND The use of acoustic signals to mask , mix with , or ease the distress associated with  tinnitus  has been clinical ly employed for decades . It has been proposed that exp and ing acoustic options for tinnitus sufferers due to personal preferences is desirable . Fractal tones incorporate many useful characteristics of music while avoiding certain features that could be distracting to some individuals . PURPOSE To assess the effects on relaxation , tinnitus annoyance , tinnitus h and icap , and tinnitus reaction from the use of a hearing aid that incorporates combinations of amplification , fractal tones , and white noise . RESEARCH DESIGN Participants listened to experimental hearing aids containing several acoustic options and were asked to rate the signals in terms of their effect on relaxation and tinnitus annoyance . They subsequently wore the hearing aids for 6 mo and completed tinnitus h and icap and reaction scales . STUDY SAMPLE Fourteen hearing-impaired adults with primary complaints of subjective tinnitus . INTERVENTION Participants were tested wearing hearing aids containing several programs including amplification only , fractal tones only , and a combination of amplification , noise , and /or fractal tones . The fractal tones ( now commercially available as the " Zen " feature ) were generated by the Widex Mind hearing aid . Rating procedures were conducted in the laboratory , and tinnitus reaction and h and icap were assessed during and following 
    Output:
    
Our primary outcomes were tinnitus symptom severity as measured as a global score on multi-item tinnitus question naire and significant adverse effects as indicated by an increase in self-reported tinnitus loudness .
The use of both types of device was associated with a clinical ly significant reduction in tinnitus symptom severity .
The use of both types of device was again associated with a clinical ly significant reduction in tinnitus symptom severity .
Adverse effects were not assessed in any of the included studies .None of the studies measured the secondary outcomes of depressive symptoms or depression , anxiety symptoms or generalised anxiety , or health-related quality of life as measured by a vali date d instrument , nor the newly developed core outcomes tinnitus intrusiveness , ability to ignore , concentration , quality of sleep and sense of control .
AUTHORS ' CONCLUSIONS There is no evidence to support the superiority of sound therapy for tinnitus over waiting list control , placebo or education/information with no device .
There is insufficient evidence to support the superiority or inferiority of any of the sound therapy options ( hearing aid , sound generator or combination hearing aid ) over each other .
Using a combination device , hearing aid or sound generator might result in little or no difference in tinnitus symptom severity .