Assessing listening effort at different SNRs in bone-anchored users

• Research type

  Research Study

• Full title

  Assessing listening effort at different signal-to-noise ratios in bone-anchored users

• IRAS ID

  270241

• Contact name

  William Brassington

• Contact email

  william.brassington@uhb.nhs.uk

• Sponsor organisation

  Oticon Medical AB

• Duration of Study in the UK

  0 years, 8 months, 16 days

• Research summary

  This single-center, single-blinded, prospective study will be conducted at the Queen Elizabeth, University Hospitals Birmingham. The study is designed to collect data from patients with a conductive or mixed hearing loss, that are already implanted with a percutaneous bone-anchored device (BAHS). The study team at Queen Elizabeth will enroll patients that have had at least six months of experience with a BAHS (Ponto).
  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. Pupil dilation can be used as an objective indicator of listening effort during the execution of a task. The aim is to compare listening effort with different settings of Ponto 4, the sound processor released by Oticon Medical AB in June 2019, in listening scenarios that differ in complexity. The study consists of three visits of about two hours each in duration, during which the patients will perform a speech-in-noise task where the listening task varies in difficulty. Pupil dilation will be recorded during the listening task as an indicator of listening effort. The patients will also use Ponto 4, instead of their own Ponto device, during a field-trial period of three months in between visit 2 and 3. Subjective evaluations of Ponto 4 will be performed via three questionnaires, one regarding self-reported performance in everyday life, one regarding work-related fatigue, and one regarding overall sound processor preference (Ponto 4 vs. patient’s own device). All these outcome measures are non-invasive measurements. This is a post market study and all products used are CE marked and used in clinical practice worldwide.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  19/EE/0257

• Date of REC Opinion

  24 Sep 2019

• REC opinion

  Further Information Favourable Opinion