Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users

NCT04242940 | Terminated Results

• 1 other identifier: BC103
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bilateral Hearing Loss

Keywords

Bone anchored hearing systems; BAHS; Listening effort; Pupillometry; Ponto 4

Outcome Measures

Primary Outcomes (1)

• Overall Pupil Dilation

  Overall pupil dilation for OSN ON and OSN OFF at +4 dB SNR a third-order polynomial function was fit to the pupil dilation data, with the OSN setting as a fixed factor, as well as the interaction of OSN with each of the polynomial time terms. The formula used is the following: Pupil Dilation = (Linear + Quadratic + Cubic) X OSN setting + (1 + Linear + Quadratic + Cubic\| Subject); where the Linear, Quadratic, and Cubic are the orthogonal terms; X indicates the interaction with OSN setting, and the terms reported in the second parenthesis are the random factors. The random factors include the effect of listeners, and of each of the time terms, to account for the variability in the time course of dilation across listeners. Outcome measure is the percentage reduction(% change) in pupil dilation with OSN ON vs OSN OFF

  10 days

Secondary Outcomes (6)

• Peak Pupil Dilation (PPD) for OSN ON and OSN OFF

  10 days

• Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs

  10 days

• Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores

  4 months

• Preference Questionnaire Scores.

  4 months

• Aided Sound Field Thresholds

  4 months

Other Outcomes (2)

• Need for Recovery (NFR) Questionnaire Scores.

  4 months

• Pupil Dilation After Field Trial.

  4 months

Study Arms (1)

Ponto 4 sound processor

EXPERIMENTAL

All patients will be fitted with a bone-anchored sound processor (Ponto 4), unilaterally or bilaterally.

Device: Fitting of Ponto 4

Interventions

Fitting of Ponto 4 DEVICE

Bone-anchored hearing systems (BAHS) use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. The intervention in this study is audiologically fitting one/two bone-anchored sound processors (Ponto 4) to patients that are already implanted with abutments.

Ponto 4 sound processor

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 patient takes medications that can impact the autonomic nervous system - and hence pupil dilation (e.g., drugs for Parkinson's disease, peptic ulcers, incontinence, motion sickness).
• If the investigator or physician assesses that the patient is not fit for trial participation.

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (1)

Audiology Department, Nuffield House, University Hospitals Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss, Bilateral

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

Oticon Medical decided to terminate the study prematurely leading to a small sample size.

Results Point of Contact

• Title: Manager of Clinical Affairs
• Organization: Oticon Medical

studyinfo@oticonmedical.com

609-366-0424

Study Officials

• William Brassington

  University Hospitals Birmingham, United Kingdom

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participants are however blinded to the Ponto 4 setting (OpenSound Navigator ON/OFF in Ponto 4) activated for each list of sentences.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: February 21, 2020
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: May 15, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-04

Locations

GB (1)