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Completed

NCT Number: NCT01715948

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

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 improving hearing and participant benefit. If the findings support the hypothesis that the CROS offers just as much benefits as the BAHD, or is an even better alternative, more individuals with SSD may choose to avoid surgery and decide to receive a CROS hearing aid instead.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with unilateral deafness (hearing loss in only one ear) who received BAHD surgery less than 3 years ago
  • Severe to profound hearing loss in the poor ear and normal hearing in the good ear
  • English speaking

Exclusion criteria

  • Adults who underwent BAHD surgery more than 3 years ago
  • Adults with hearing loss in both ears
  • Adults who received a BAHD to treat a condition other than unilateral deafness (such as bilateral conductive hearing loss)

Treatment and study plan

CROS hearing aid

Device

Participants were randomly assigned to be fitted with the CROS hearing aid either at the end of the first visit or at the end of the second visit. They were given a 2-week trial with the CROS and asked to refrain from wearing their BAHD during that time. At the end of the first visit, four participants were fitted with the CROS hearing aid and were subsequently tested with this device on their second visit, at which time they were instructed to use the BAHD for the next 2 weeks. This protocol was reversed in the other four participants, with testing after each device experience. Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.

Other names: Unitron Tandem 4 CROS hearing aid

Bone-anchored hearing device (BAHD)

Device

All participants had received BAHD implantation prior to the study. They were randomly selected to continue wearing their BAHD for 2 weeks following the end of the first visit or the end of the second visit. Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.

Primary outcomes

  1. 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.

  2. 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 was presented at 50 dB HL at 90 degrees to the poor ear in quiet. In the second condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was presented at 45 dB HL at 90 degrees to the poor ear. In the final condition, the words were presented at 50 dB HL at 0 degrees while multitalker noise was delivered at 45 dB HL at 90 degrees to the better ear.

  3. Speech Spatial Qualities Questionnaire (SSQ)

    Time frame: Administered at the end of a 2 week trial with the CROS and at the end of a 2 week use of the BAHD.

    The Speech Spatial Qualities Questionnaire (SSQ) was given to assess the self-perceived benefits provided by the device that was worn the previous 2 weeks. The SSQ requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 ("Not at all") to 10 ("Perfectly"). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. Therefore, a lower score indicated poorer self-perceived benefit from the device (representing a worse outcome), while a higher score indicated greater self-perceived benefit from the device (representing a better outcome). To obtain individual scores for the SSQ questionnaire, the ratings for each listening scenario were summed. The mean, minimum and maximum scores for each subscale of the SSQ across all participants were also determined.

Sponsors and collaborators

Lead sponsor

Manohar Bance

Other

Collaborators

  • Dalhousie University

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 29, 2012
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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