Evaluation of the Baha SoundArc in Pediatric Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-02

Study Completion Date

2018-11-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to gather clinical performance data on the Baha SoundArc

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness

NCT00201617

Unilateral Deafness

COMPLETED

Clinical Performance of a Transcutaneous Bone Conduction Hearing Solution (Baha® Attract System)

NCT01822119

Deafness Hearing Loss Hearing Loss, Conductive

COMPLETED NA

Post-market Clinical Follow-up of a Magnetic Bone Conduction Implant (Cochlear Baha Attract System)

NCT02022085

Deafness Hearing Loss Hearing Loss, Conductive

COMPLETED NA

Clinical Evaluation of Bass and Treble Controls for CI Subjects

NCT02908737

Hearing Loss

COMPLETED NA

Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation

NCT06301568

Cochlear Hearing Loss

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Current Baha recipients that are using a Baha SoftBand will be recruited to be fitted with an alternative non-surgical option for using their Baha Sound Processor. The subjects will be tested with there existing Baha Sound Processor on the SoftBand and will then be fitted with the Baha SoundArc where they will perform a one month take home trial. At the end of this trial, the subject will return for testing and evaluation of their experience with this new fitting option.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Loss, Conductive Hearing Loss, Mixed Hearing Loss, Unilateral

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental SoundArc study group

all subjects will receive the SoundArc intervention

Group Type EXPERIMENTAL

SoundArc

Intervention Type DEVICE

non-surgical attachment method for wearing a bone conduction hearing system

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SoundArc

non-surgical attachment method for wearing a bone conduction hearing system

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects aged 5 through 12 years of age
* Subjects should be able to perform clinical testing adapted for age and developmental status, (Threshold sound field audiometry and basic monosyllabic word test, PBK)
* Willingness on behalf of the subject's parent or guardian to complete study questionnaire