Bone conduction devices in minimal air-bone gaps
| ISRCTN | ISRCTN84707929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84707929 |
| IRAS number | 332538 |
| Secondary identifying numbers | CPMS 61324; Grant Code: IIR-2480 |
- Submission date
- 18/06/2025
- Registration date
- 23/06/2025
- Last edited
- 23/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
Background and study aims
Bone conduction devices (BCDs) are hearing aids which are given to people with a mixed or conductive hearing loss to improve their hearing. These devices deliver sounds to the patient by sending vibrations through the skull to stimulate the hearing organ. This study is looking to see if patients with a smaller degree of mixed or conductive hearing loss than would normally be considered for a BCD also benefit from a BCD when we compare their speech understanding with their conventional hearing aid.
Who can participate?
Adults (18 years of age and above) who are willing and able to provide written informed consent and are air conduction hearing aid (ACHA) users (including bilateral hearing aid users) with a recent fitting (<6 months)
What does the study involve?
Participants will be invited to two appointments at the hospital. At the first appointment an audiologist or a member from the research team will talk through the study and ask the participant to sign a consent form. A hearing test and some listening tests with the participant's current hearing aid(s) will be conducted. In addition, the participant will fill in some questionnaires about how they are feeling, and how well they are listening with their hearing aid(s). The local audiologist who is part of the research team will then fit a BCD on a softband for the participant to try out for 2 weeks. In about 2-6 weeks, the participant will come back to the hospital once for some more listening tests, this time with the BCD fitted in the previous appointment. A few more questionnaires on how listening with the BCD was and how it was different to their regular hearing aid(s) will also be filled out by the participant.
What are the possible benefits and risks of participating?
During the study period we do not anticipate any problems, but if any occur you can contact your local department for advice. The study hearing aid is fitted on a softband, which may or may not cause some discomfort when worn for a longer period of time.
Where is the study run from?
University College London Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2023 to March 2027
Who is funding the study?
Cochlear, who provide the study hearing aid, provide funding for the study but they are not in charge of any study operational matters and the study is fully sponsored by the University College London Hospital (UK)
Who is the main contact?
Mr Mark Chung, bcdabg.uclh@nhs.net
Contact information
91 Gower Street
London
WC1E 6AB
United Kingdom
| f.long@ucl.ac.uk |
Scientific
Level 4, 179A Tottenham Court Road
London
W1T 7PA
United Kingdom
| Phone | +44 (0)3000 332 443 |
|---|---|
| bcdabg.uclh@nhs.net |
Study information
| Study design | Non-randomized; Interventional; Design type: Treatment, Device, Active Monitoring |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Benefit from bone conduction devices in patients with minimal air-bone gaps |
| Study objectives | The primary study hypothesis is that patients with a small air-bone gap will have higher aided speech recognition in noise (measured using the Bamford-Kowal-Bench [BKB] test) when using bone conduction devices (BCDs) compared to conventional air conduction hearing aids (ACHAs). |
| Ethics approval(s) | Approved 29/05/2024, South Central - Oxford A REC (Ground Floor Temple, Quay House, 2 The Square, Bristol, BS1 6PN, UK; +44 (0)207 104 8118; oxforda.rec@hra.nhs.uk), ref: 24/SC/0140 |
| Health condition(s) or problem(s) studied | Hearing loss |
| Intervention | Patients will be identified by hearing aid centres or by a search through the hospital's audiology database. Patients will be invited to participate via letter and sent a patient information sheet about the study, and asked to contact the clinic if they are interested in participating. Patients will then be offered two appointments. At the first appointment: The patient will be consented to the study If the patient consents to the study: Their hearing will be checked to make sure it still fits the protocol We will ask them about their hearing history and collect some basic demographic data (age in years, sex and ethnicity) We will then test their speech understanding/listening with their hearing aids (ACHA) We will take a reading from their hearing aids to see how much they wear them We will ask them to fill in questionnaires: 1. The HUI3 to ask about quality of life factors 2. The SSQ12 to ask about how they hear with their ACHA 3. The HHIA to ask about their perceived difficulties in hearing with the ACHA 4. Part 1 of the GHADP We will then fit them with a trial BCD on a softband for them to use for 4 weeks (+/-2 weeks). We will ask them to wear it as much as possible until their next appointment. The patient will then have a second appointment approximately 4 weeks later (+/- 2 weeks). At the second appointment: The patient will repeat the speech testing, but with the BCD this time. We will take a reading from the BCD to see how much it was worn. We will ask the participant to fill in the same questionnaires again, but relating to the BCD device they trialled. We will also ask them to fill in part 2 of the GHADP questionnaire to see if there are any differences between the two devices (ACHA vs BCD). If the patient finds the trial successful, and they wish to discuss a BCD in more detail, they will be offered an appointment with an ENT consultant and move into the normal NHS BCD assessment pathway for the department. Recruiting sites will send pseudanomymised data to UCLH for statistical analysis. We do not expect any commercial intellectual property to be generated by this study; however, if these do arise, they will belong to UCLH as stated in the protocol. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bone conduction devices |
| Primary outcome measure | Speech discrimination scores (assessed by BKB sentences and AB word lists) are compared between an acoustic hearing aid at baseline and with a bone conduction device after a 4-week (+/- 2 weeks) trial |
| Secondary outcome measures | Patient-reported outcome measures assessed by questionnaires at baseline and after 4 weeks (+/- 2 weeks trial): 1. Quality of life measured using Health Utilities Index (HUI-3) 2. Hearing disability in everyday situations assessed using Speech, Spatial, and Qualities of Hearing Scale 12-item version (SSQ-12) 3. Perceived hearing handicap assessed using the Hearing Handicap Inventory for Adults (HHIA) 4. Differences in perceived benefit between the two devices measured using the Glasgow HA difference profile (GHADP) |
| Overall study start date | 18/04/2023 |
| Completion date | 01/03/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Key inclusion criteria | 1. Adults (18 years of age and above) 2. Willing and able to provide written informed consent 3. ACHA user (including bilateral HA users) with recent fitting or HA adjustment (<6 months) 4. ABG between 15-30 dB (averaged over 0.5-2 kHz), with absolute unmasked BC thresholds <55 dBHL |
| Key exclusion criteria | 1. Inability to wear ACHA consistently 2. Inability to perform English speech tests and complete questionnaires independently 3. Rapidly changing or fluctuating hearing loss |
| Date of first enrolment | 24/06/2024 |
| Date of final enrolment | 30/09/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
WC1E 6DG
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sheffield
S10 2JF
United Kingdom
Edgbaston
Birmingham
B15 2TH
United Kingdom
Basingstoke
RG24 9NA
United Kingdom
Stevenage
SG1 4AB
United Kingdom
Sponsor information
Hospital/treatment centre
250 Euston Road
London
NW1 2PG
England
United Kingdom
| Phone | +44 (0)203 447 5369 |
|---|---|
| uclh.randd@nhs.net | |
| Website | https://www.uclh.nhs.uk/Pages/home.aspx |
"ROR" |
https://ror.org/042fqyp44 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
18/06/2025: Study's existence confirmed by the NIHR.
