Response to Letter to the Editor: RE

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We appreciate the issues raised by Dr. Hall and her thoughtful comments concerning the need to provide additional data to inform a randomized controlled trial (RCT) that would definitively answer the research question “Are combination instruments more effective than hearing aids for reducing effects of tinnitus?” As noted by Dr. Hall, the present study was a pilot investigation and, as such, was designed to provide preliminary data to address the research question; indeed, the findings suggested that further study is warranted (Hall, in press).
The question as to whether combination instruments are superior to hearing aids for reducing tinnitus symptoms is an important one that is relevant to millions of individuals who have both hearing loss and tinnitus. All of the major hearing aid manufacturers currently provide combination instruments, and clinicians are often faced with the choice of fitting either a hearing aid or a combination instrument to their patients who complain of tinnitus. Definitive data are needed to make evidence-based decisions, and we are therefore pleased to provide the requested data from our study.
Three specific requests for data were made: (1) a breakdown of change scores (pre- to postintervention) for each of the eight subscales on the Tinnitus Functional Index (TFI); (2) a power analysis based on this study’s data to estimate the sample size needed to definitively answer the research question; and (3) a power analysis of binary TFI data reflecting the proportions of participants who showed a “meaningful improvement” in their tinnitus condition, which would require analysis using a χ2 test.
It should be mentioned that a second study comparing hearing aids and combination instruments was recently completed (Henry et al., 2016). This second study included a total of 55 participants who were randomized to one of three arms: conventional hearing aids, combination instruments, and deep-fit extended-wear hearing aids (Lyric). This study provided a single outcome measure—pre- and postintervention TFI—that assessed overall outcomes (i.e., not separately for “with” versus “without” hearing aids). With respect to the need to inform a large RCT comparing the efficacy of hearing aids to combination instruments, this second study will provide important additional data.
We once again appreciate Dr. Hall’s interest in our publication and hope the additional information provided here will further efforts toward conducting a large-scale RCT that will definitively answer this important research question.
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