Audiological Benefit With Non-implantable Bone Conduction Hearing Systems

NCT03129191 | Completed

• 1 other identifier: HRL-NIBCH
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, a new non-invasive bone conduction hearing aid was introduced. The system is connected directly to the skin with an adhesive adapter to transmit the sound to the inner ear through bone vibrations. The objective of this study is to evaluate and compare the audiological benefit of the new bone conduction hearing aid and compare it to an existing bone conduction hearing aid in normal hearing adults with bilateral simulated conductive hearing loss. An evaluation of the improvement on speech understanding in noise and sound localization allows to estimate the system performance and enables to derive recommendations for clinical usage of the novel hearing system. It is hypothesized that in the bilateral condition similar speech understanding in noise and sound localization performance can be achieved with the new system compared to existing bone conduction hearing aids that are pressed against the skull using a soft band.

Conditions

Hearing Loss, Conductive

Outcome Measures

Primary Outcomes (1)

• Speech reception threshold in noise (S0NDIFF)

  Speech reception threshold in noise (in dB SNR) measured with speech presented from the front (0° azimuth) and approximated diffuse noise presented from 4 speakers.

  Day 1

Secondary Outcomes (4)

• Speech reception threshold in noise (S90NDIFF)

  Day 1

• Speech reception threshold in noise (S270NDIFF)

  Day 1

• Sound localization

  Day 1

• Subjective evaluation of the sound quality

  Day 1

Study Arms (2)

AB arm

ACTIVE COMPARATOR

Sequence: 1. Aided with non-invasive bone conduction hearing aid A 2. Aided with non-invasive bone conduction hearing aid B

Device: Non-invasive bone conduction hearing aid A; Device: Non-invasive bone conduction hearing aid B

BA arm

ACTIVE COMPARATOR

Sequence: 1. Aided with non-invasive bone conduction hearing aid B 2. Aided with non-invasive bone conduction hearing aid A

Device: Non-invasive bone conduction hearing aid A; Device: Non-invasive bone conduction hearing aid B

Interventions

Non-invasive bone conduction hearing aid A DEVICE

The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband.

AB arm; BA arm

Non-invasive bone conduction hearing aid B DEVICE

The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an adhesive adapter that is placed behind the auricle.

AB arm; BA arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Adults (age ≥ 18 years on the test date)
• Normal hearing thresholds (AC/BC-thresholds ≤ 20 dB HL, 0.25 to 8 kHz)
• German native speakers
• Willingness and ability to perform all tests required for the study

You may not qualify if:

• Allergy against silicon (ear mold casting mass)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Hearing Research Laboratory, University Hospital Bern

Bern, 3008, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss, Conductive

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

Study Officials

• Martin Kompis, Prof

  University Hospital Bern, Inselsptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 26, 2017
• Study Start: July 1, 2017
• Primary Completion: November 6, 2017
• Study Completion: November 6, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

CH (1)