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Use of RM Technology in Pediatric BAI Recipients

Remote Microphone Technology in Pediatric Bone Anchored Implant Recipients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03149484
Enrollment
20
Registered
2017-05-11
Start date
2017-05-02
Completion date
2019-04-11
Last updated
2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Unilateral

Brief summary

The purpose of this research study is to learn about the hearing outcomes of children with conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology.

Detailed description

The purpose of this research study is to learn about the hearing outcomes of children with unilateral conductive hearing loss who are treated with bone conductive devices and their outcomes with remote microphone technology. It has been shown that the use of intervention (hearing aids, cochlear implants, bone conduction devices) alone does not alleviate the difficulties children with hearing loss encounter in noisy environments such as a classroom or restaurant. One of the most common methods to help children hear better in these types of environments is the use of a personal remote microphone (RM) system. This study will evaluate how much benefit children are getting from their bone conduction device alone compared to the bone conduction device with a personal RM system.

Interventions

DEVICEPersonal remote microphone (RM) system

Speech perception in noise performance will be evaluated in the unaided, bone conduction device (BAHA) aided, and bone conduction device (BAHA) + RM conditions. All test measures are non-experimental and commercially available.

These subjective questionnaires will be given pre- and post-evaluation to both the subject and their guardian in order to determine the impact of RM on subject and guardian perceptions of listening in noise.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* English speaking * unilateral conductive hearing loss with a minimum of a 30 dB air-bone gap and their parent/guardian

Exclusion criteria

* Do not meet inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Speech Understanding in Noise40 minutesInvestigate benefit of remote microphone (RM) for listening in noise in children with bone conduction hearing devices by calculating SNR loss
Parent and Child Perception of Hearing Loss Questionnaire20 minutesDetermine the parent and child perception of the hearing loss and its impact pre- and post-evaluation using a subjective questionnaire created to further understand the child and parent's perception of their disability.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026