NCT04006132

Brief Summary

The purpose of this study is to evaluate the benefit of bilateral implantation with bone-anchored hearing systems (BAHS), in terms of sound localization abilities, as well as auditory working memory. The hypothesis is that the use of two BAHS (bilateral condition) will not only improve localization abilities, but it will also increase the ability to retain words in working memory, compared to performance with only one BAHS (unilateral condition).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

July 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

June 27, 2019

Last Update Submit

January 22, 2020

Conditions

Bilateral Hearing Loss

Keywords

Bone anchored hearing systemsBAHSBilateral benefitPonto 3 SuperPowerMinimum Audible AngleAuditory working memory

Outcome Measures

Primary Outcomes (1)

  • Minimum Audible Angle test

    Minimum angle at which noise bursts are accurately localized (Right/Left) in the unilateral and bilateral conditions

    4 months

Secondary Outcomes (2)

  • SWIR test

    4 months

  • SSQ12

    4 months

Study Arms (1)

Ponto 3 SuperPower sound processor

EXPERIMENTAL

All patients will be fitted with two bone-anchored sound processors (Ponto 3 SuperPower), unilaterally and bilaterally.

Device: Fitting of Ponto 3 SuperPower

Interventions

Fitting of Ponto 3 SuperPowerDEVICE

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 two bone-anchored sound processors (Ponto 3 SuperPower) to patients that are already bilaterally implanted with abutments.

Ponto 3 SuperPower sound processor

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult BAHS users, minimum 18 years and maximum 75 years.
  • Native English speakers.
  • Patients that are already bilaterally implanted.
  • Patients with a bilateral conductive or mixed conductive-sensorineural hearing loss.
  • Experience with bilateral Ponto of at least 6 months.
  • Patients that are using both their sound processors daily.
  • PTA BC (at 0.5, 1, 2, 3 kHz) on both sides lower or equal to 65 dB HL.
  • If the masked BC is available on the patient's journal, the average difference in masked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.
  • If the masked BC is not available on the patient's journal, the average difference in unmasked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.

You may not qualify if:

  • Not deemed suited by the principal investigator.
  • If the physician assesses that the patient is not fit for trial participation at any stage.
  • Audiogram at 1st visit shows too large masked BC thresholds (PTA BC - at 0.5, 1, 2, 3 kHz - on either side larger than 65 dB HL).
  • Audiogram at 1st visit shows asymmetric masked BC thresholds (average difference in masked BC - at 0.5, 1, 2, 4 kHz - between L and R ear larger or equal to 15 dB).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Brassington

    University Hospitals Birmingham, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The participants are blinded to the tested condition (unilateral vs bilateral)
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 5, 2019

Study Start

July 4, 2019

Primary Completion

January 7, 2020

Study Completion

January 10, 2020

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

GB(1)