Evaluation of Open-canal Behind-the-Ear Hearing Aids and Traditional In-the-ear Hearing Aids.
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      This study is being conducted to evaluate the benefits of in-the-ear vs. open-fit
      behind-the-ear hearing aids. We want to learn more about which patients prefer each type, so
      we can make better choices about which type of hearing aid is best for which patients.
      Participants in this study will try three different sets of hearing aids for 2 months each,
      then we will evaluate the benefit of each type. Participants must be Veterans who are
      eligible for audiology care at one of the three participating sites.
    

Detailed description: 
      Hearing loss is the most common service-connected disability nationwide in the Veteran's
      Health Administration (VHA) system, with hearing aids providing the primary treatment option.
      Although the benefits of hearing-aid use are clearly established,~16-30% of adults who have
      hearing aids do not use them. Several factors are believed to result in non-use of
      traditional hearing aids, including (1) poor fit and comfort, (2) poor cosmetics, (3)
      whistling feedback, (4) occlusion, and (5) difficulty understanding speech in noise.

      Recently, the open canal (OC) hearing-aid style has become a viable approach to addressing
      address many of the problems resulting in non-use of traditional hearing aids, particularly
      for individuals with mild to moderately-severe hearing loss. Although an OC hearing aid has
      many potential advantages, there also are potential limitations. For example, the maximum low
      and high-frequency gain available with an OC fitting is less than that available from
      traditional custom (TC) hearing-aid fittings, which could result in less than optimal
      amplification for some individuals. In addition, directional microphone benefits for speech
      understanding in noise, available with TC fittings, likely will be limited with OC fittings
      due to the loss of low-frequency gain (Ricketts et al., 2005).

      Since both OC and TC fittings are appropriate for listeners with mild to moderately-severe
      hearing losses, evidence is needed to determine which style of hearing aid is preferred by a
      majority. Currently, OC fittings use a small behind-the-ear (BTE) hearing aid coupled to a
      thin tube or plastic covered wire ending in a vented "open" ear tip. When a TC fitting is
      used with patients with similar hearing losses, the majority are either an in-the-ear (ITE)
      or in-the-canal (ITC) .In the proposed study a comparison will be made between OC vs. TC
      fittings. In addition to this primary comparison, preference for one of two OC hearing aids,
      viz., OC instruments with receiver in the ear (OCRITE) and the OC instruments with receiver
      in the hearing-aid case (OCRIHA), will be determined. The outcomes of the OCRITE, OCRIHA, and
      TC hearing-aid use related to the factors of: (1) comfort and cosmetics, (2) subjective
      occlusion, (3) objective occlusion, (4) sound quality for external sounds, (5) feedback, (6)
      ease of use, (7) audibility, (8) aided signal-to-noise ratio (SNR) benefit, and (9)
      localization, will be measured in a large (n = 288), randomized-controlled, three-site (Bay
      Pines, Mountain Home, and Nashville) clinical trial, utilizing a three-period (two months
      each), cross-over design. A total of 13 variables will be measured for the 9 hearing-aid
      fitting and style-related factors. At the end of the study, participants will rank order
      their preferences for the three hearing aid fittings to determine (1) the preferred OC
      fitting (OCRITE vs. OCRIHA) and (2) whether the highest ranked OC fitting or the TC fitting
      is preferred. Preferred OC vs. TC difference scores will be calculated for all relevant
      variables. The ability of the differences scores to predict the preferences of the
      participants for an OC vs. TC hearing aid will be determined, in order to develop an
      evidence-based hearing aid selection model.
    

Intervention name(s): Hearing Aid Treatments
Intervention type(s): Device
Intervention description(s): Hearing aid treatments:
Traditional Custom (TC), Receiver-in-the Aid (RITA) and Receiver-in-the-Ear (RITE)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hearing loss; Hearing Aids; Speech Perception; Persons with Hearing Impairment