Clinical Trial: A Comparison Between Wireless CROS and Bone-anchored Hearing Devices for Single-Sided Deafness: A Pilot Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Comparison Between Wireless CROS and Bone-anchored Hearing Devices for Single-Sided Deafness: A Pilot Study

Brief Summary:

People with single-sided deafness (SSD) have significant hearing loss in one ear and normal or near normal hearing in the other ear. Those living with SSD experience several communication difficulties, particularly when listening to speech in the presence of background noise. This problem is worse in situations where the noise is on the side of the good ear and the speech is on the side of the poor ear.

The Bone-anchored hearing device (BAHD) and the Contralateral Routing of Signals (CROS) hearing aid are two intervention methods designed to improve hearing in people who have significant hearing loss in one ear only. The BAHD is a surgically implanted device which also includes an external processor; sounds from the poor ear are transmitted to the good ear through skull vibrations. The CROS does not involve surgery; instead a hearing aid is fitted behind each ear, and the sounds on the side of the poor ear are wirelessly transmitted to the good ear.

The majority of previous studies comparing the BAHD to the CROS have used older CROS models with basic technology and a wire along the neck to send sounds from the poor ear to the good ear. There is a lack of studies comparing newer digital wireless CROS hearing aids to the BAHD. The current research will compare the effect of the BAHD and CROS hearing aid on speech perception scores when listening to speech in quiet and in noise. The research will also investigate participants' reported benefits with each device during everyday situations. In order to compare the BAHD and CROS, individuals who already have been implanted with a BAHD will be given a trial period with a new wireless digital CROS hearing aid.

The research hypothesis states that the CROS hearing aid will be as equally beneficial or greater than the BAHD in improvin

Detailed Summary:

Users of the BAHD will be given a 2-week trial period with the Unitron Tandem CROS hearing aid. Participants will be randomly assigned to wear either their BAHD for two weeks or the trial CROS for two weeks. There will be a total of three visits made to the clinic.

During each visit:

  • Participants' hearing will be tested (either with the BAHD, the CROS, or without wearing any device).
  • Speech perception ability will be tested in quiet and in noise conditions (either while wearing the BAHD, the CROS, or no device).
  • Participants will be asked to complete two standardized questionnaires on the perceived benefits that the BAHD or the CROS provides.

In addition, participants will be asked to fill out a short diary form every day, for a two-week period, to report the situations in which they wore the device.


Sponsor: Manohar Bance

Current Primary Outcome:

  • Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise [ Time Frame: The QuickSIN unaided was administered at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested). ]
    One speech-in-noise test (QuickSIN) presented four lists of six pre-recorded sentences at 50 dB hearing level (HL) in soundfield. Multitalker noise was presented together with the target sentence and increased at a fixed number of dB with the completion of each sentence. The multitalker noise was initially presented at 25 dB HL (signal-to-noise ratio - SNR of 25 dB), and increased by 5 dB after each sentence until the multitalker noise was of equal intensity with the final sentence (SNR of 0 dB). In one condition, two lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the poor ear. In the other condition, two different lists of sentences were presented to the participant at 0 degrees with the multitalker noise delivered at 90 degrees to the better ear. The two scores derived from the two different lists of sentences presented within each condition were averaged. A low score indicates better performance.
  • Percentage of Words Recognized [ Time Frame: Word recognition testing (unaided) occurred at baseline, an average of 2 weeks (with CROS or BAHD) and an average of 4 weeks (with opposite device not previously tested).. ]
    Word recognition was tested with the recorded version of the Central Institute for the Deaf (CID) W-22 (Auditec of St. Louis), with a different list of 25 monosyllabic words presented at 50 dB HL in three randomized listening conditions. In the first condition, one list

    Original Primary Outcome: Speech-in-noise test (QuickSIN) [ Time Frame: The QuickSIN will be administered unaided (no device) during the first visit to the clinic, and will be administered again at the end of a two-week trial with the CROS and at the end of a two-week use of the BAHA. ]

    The QuickSIN is a speech in noise test. Participants are asked to repeat sentences while listening in multi-talker background noise.


    Current Secondary Outcome:

    Original Secondary Outcome:

    • Bern Benefit in Single-Sided Deafness Questionnaire (BBSS) [ Time Frame: Will be administered at the end of a two-week trial with the CROS and at the end of a two-week use of the BAHA. ]
      The BBSS is a 10-item questionnaire that measures participants' perceived benefit from their BAHA or CROS hearing aid. The items examine different situations in which participants score the benefit derived from their device with ratings that range from -5 ("Much Easier Without the Aid") to +5 ("Much Easier With the Aid").
    • Speech Spatial Qualities Questionnaire (SSQ) [ Time Frame: Will be administered at the end of a two-week trial with the CROS and at the end of a two-week use of the BAHA. ]
      The Speech Spatial Qualities Questionnaire describes 49 scenarios in which participants may experience difficulty hearing. For both the BAHA and CROS, participants will be asked to rate their perceived hearing ability for all scenarios on a 10-point scale, ranging from "Not at all" to "Perfectly".


    Information By: Nova Scotia Health Authority

    Dates:
    Date Received: October 23, 2012
    Date Started: January 2013
    Date Completion:
    Last Updated: March 7, 2016
    Last Verified: March 2016