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

NCT01715948 | Completed Results

• 1 other identifier: CDHA-RS/2013-118
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Unilateral Hearing Loss; Unilateral Deafness

Keywords

CROS hearing aid; Bone-anchored hearing device

Outcome Measures

Primary Outcomes (3)

• Number of 5 Key Words Within 6 Sentence Lists Repeated Correctly in the Presence of Multitalker Noise

  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.

  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).

• Percentage of Words Recognized

  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.

  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)..

• Speech Spatial Qualities Questionnaire (SSQ)

  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.

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

Study Arms (2)

CROS hearing aid

EXPERIMENTAL

The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted with a retainer earhook on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to a slim tube and open ear tip. The CROS does not amplify sound but rather transmits sound from the side of the unaidable ear to the contralateral ear, overcoming the head shadow effect that presents with SSD.

Device: CROS hearing aid

Bone-anchored hearing device (BAHD)

EXPERIMENTAL

The BAHD (such as the Baha by Cochlear or Bone-Bridge by MED-EL) also helps to alleviate the negative effect of head shadow and the difficulty with speech perception in noise that present with SSD. Also known as an osseointegrated aural prosthesis, the BAHD is implanted in individuals with SSD to stimulate the ear with the normal cochlea. The BAHD requires that a titanium screw be surgically implanted in the temporal bone on the side of the poor ear. This titanium screw is connected to a percutaneous abutment. An electromechanical sound processor (external transducer) is coupled onto the abutment and can be removed when necessary. Sound can now be routed to the better ear by transcranial bone conduction.

Device: Bone-anchored hearing device (BAHD)

Interventions

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.

Also known as: Unitron Tandem 4 CROS hearing aid

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.

Bone-anchored hearing device (BAHD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Manohar Bance: lead
• Dalhousie University: collaborator

MeSH Terms

Conditions

Hearing Loss, Unilateral

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The sample size was small and included only one male. The trial period of two weeks was short and may not have provided enough time for participants to adjust to the new CROS. The long-term benefit of both hearing devices needs to be assessed.

Results Point of Contact

• Title: Dr. Manohar Bance
• Organization: Capital Health

m.bance@dal.ca

902-473-5975

Study Officials

• Manohar Bance, FRCS

  Capital Health, Canada

  PRINCIPAL INVESTIGATOR

• Rachel Caissie, Ph.D.

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Jennifer Finbow, B.Sc.

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician Division of Otolaryngology

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: October 29, 2012
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 5, 2016
• Results First Posted: April 5, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share