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Bone conduction devices in minimal air-bone gaps

Benefit from bone conduction devices in patients with minimal air-bone gaps

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84707929
Enrollment
60
Registered
2025-06-23
Start date
2024-06-24
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing loss Ear, Nose and Throat

Interventions

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 abo

Sponsors

University College London Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026