NCT04147611

Brief Summary

The purpose of this investigation is to evaluate objective outcomes in pediatric bone conduction hearing device (often termed "BAHA") users with and without remote microphone (RM) technology. In this study, two remote microphone technologies will be evaluated to determine benefit in speech understanding in noise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

Study Start

First participant enrolled

October 21, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 23, 2021

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

October 30, 2019

Results QC Date

June 30, 2021

Last Update Submit

April 24, 2023

Conditions

Hearing Loss, Conductive

Outcome Measures

Primary Outcomes (1)

  • Percentage of Correct Word Responses

    Percentage of correct word responses as assessed via the Pediatric AZBio Sentence List test at -10 decibels (dB) signal to noise ratio. The total score ranges from 0-100% with the higher score indicating increased listening in noise performance.

    2 hours

Study Arms (2)

Remote Microphone (RM) Technology Group

EXPERIMENTAL

The RM technology group will limited to the pediatrics participants. Participants will be tested separately on the three following conditions: 1. Bone Conduction Device (BAHA) only 2. BAHA + Wireless Audio-Streaming Accessory 3. BAHA + Digital Adaptive RM System

Device: BAHADevice: Wireless Audio Streaming AccessoryDevice: Digital Adaptive RM System

Normal Hearing Controls

ACTIVE COMPARATOR

The normal hearing controls will be limited to 15 adults. Participants will be tested separately on the six following conditions: 1. Unaided 2. Unilateral hearing aid with contralateral plug. 3. Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova) 4. Bone Conduction Device (BAHA) only 5. BAHA + Wireless Audio-Streaming Accessory 6. BAHA + Digital Adaptive RM System

Device: BAHADevice: Wireless Audio Streaming AccessoryDevice: Digital Adaptive RM SystemDevice: Hearing Aid

Interventions

BAHADEVICE

Participant's pediatric bone conduction hearing device.

Normal Hearing ControlsRemote Microphone (RM) Technology Group
Wireless Audio Streaming AccessoryDEVICE

Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device.

Normal Hearing ControlsRemote Microphone (RM) Technology Group
Digital Adaptive RM SystemDEVICE

Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.

Normal Hearing ControlsRemote Microphone (RM) Technology Group
Hearing AidDEVICE

Participant's unilateral hearing aid with contralateral plug.

Normal Hearing Controls

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking pediatric conduction device users and their guardian/s will be included for study.
  • We will include pediatric patients 5 years of age to 17 years of age who have a conductive or mixed unilateral or bilateral hearing loss with a minimum of a 30 decibels (dB) air-bone gap.

You may not qualify if:

  • Normal Hearing Controls:
  • Adults greater than18 years of age.
  • Hearing thresholds \< 25 dB 500 - 4,000 Hz.
  • \- Non-English speakers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristine Harris

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hearing Loss, Conductive

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Results Point of Contact

Title
Dr. Hillary Snapp
Organization
University of Miami
hsnapp@med.miami.edu
305-243-4611

Study Officials

  • Hillary Snapp, AuD, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 1, 2019

Study Start

October 21, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

April 26, 2023

Results First Posted

July 23, 2021

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)