Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users (NCT04242940) | Clinical Trial Compass
TerminatedNot Applicable
Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users
Stopped: The sponsor decided to terminate the study prematurely given that patient enrollment was delayed by more than two years relative to what originally stated in the protocol.
United Kingdom14 participantsStarted 2020-02-21
Plain-language summary
The purpose of this study is to assess listening effort during a speech-in-noise task in bone-anchored hearing systems (BAHS) users via pupillometry.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Minimum 18 years and maximum 70 years old.
* UK English mother tongue.
* Bilateral conductive or mixed hearing loss.
* Users fitted unilaterally or bilaterally on abutment.
* Users are currently fitted with either Ponto 3, Ponto Plus or Ponto Pro (devices with a fitting range up to 45 dB HL).
* Users with at least 6 months of daily experience with one Ponto sound processor.
* BC thresholds of the implanted ear(s) better (lower) than or equal to 40 dB HL (average of 0.5, 1, 2 and 3 kHz) based on BC in-situ measurement at the first visit.
* People currently employed/self-employed (since the Need for Recovery questionnaire refers to work-related fatigue).
* Speech recognition scores better (higher) than or equal to 50% at +4 dB SNR with OSN OFF (as assessed via the first training list at Visit 1). This is to avoid including patients that are already "giving up" at +4 dB SNR.
* Users entitled for a sound-processor upgrade (according to the investigator) will first be selected. If there are not enough users entitled for an upgrade, then patients fitted with Ponto between 7 and 12 months before visit 1 will be considered. If there are not enough users within 7-12 months, then patients fitted with Ponto between 13 and 18 months before visit 1 will be considered.
Exclusion Criteria:
* Single-sided deafness (SSD)
* Hearing aid or cochlear implant on the opposite ear.
* Test persons with current eye diseases and/or history of eye surgery on both eyes.
* If the …