Evaluation of Sound Processor for a Transcutaneous System

Single Center Evaluation of a Sound Processor for a Transcutaneous System

A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and speech intelligibility and self evaluation questionnaires.

Study Overview

• Status: Completed
• Conditions: Conductive Hearing Loss; Mixed Hearing Loss
• Intervention / Treatment: Device: Fusion Sound Processor

Detailed Description

Bone conduction hearing systems 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. Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound processor used for a transcutaneous system.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 46
    • ENT departement, Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects implanted with the Bridging Bone Conductor (BBC) implant
• Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study
• Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study
• Active user of the BCI SP

Exclusion Criteria:

• Inability to participate in follow-ups
• Unsuitable as judged by the principle investigator or the sub-investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fusion sound processor; The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.	Device: Fusion Sound Processor; Sound Processor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aided thresholds Fusion-unaided PTA	Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aided thresholds Fusion-unaided	Difference between Fusion-aided and unaided sound field Pure Tone thresholds at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz	6 months
Aided thresholds Fusion PTA4	Difference between Fusion-aided sound field PTA4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)	Baseline, 1 and 6 month(s)
Aided thresholds Fusion	Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at	Baseline, 1 and 6 month(s)
Aided thresholds Fusion-BCI PTA4	Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4)	6 months
Aided thresholds Fusion-BCI	Difference between Fusion-aided and BCI-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz	6 months
Speech intelligibility Fusion-unaided %	Difference between Fusion-aided and unaided speech intelligibility scores (in % correct)	6 months
Speech intelligibility Fusion-unaided signal to noise ratio (SNR)	Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR	6 months
Speech intelligibility Fusion %	Difference between Fusion-aided speech intelligibility scores (in % correct)	Baseline, 1 and 6 month(s)
Speech intelligibility Fusion SNR	Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR	Baseline, 1 and 6 month(s)
Speech intelligibility Fusion-BCI %	Difference between Fusion-aided BCI-aided speech intelligibility scores (in % correct)	6 months
Speech intelligibility Fusion-BCI SNR	Difference between Fusion-aided and BCI-aided sound field speech intelligibility scores in SNR	6 months
Magnet strength	Difference in magnet strength measured on the patient's heads in Newton	Baseline, 1 and 6 month(s)
IPS (Inflammation, Pain, Skin height/numbness) evaluation	Combined score of IPS evaluating the skin area under the sound processor. I scale ranging from 0-4, Pain scale ranging from 0-2, Skin height/numbness ranging from 0-2. Total score 0-8 (0 no adverse skin condition, 8 maximum adverse skin reactions on all subscales)	Baseline, 1 and 6 month(s)
Subjective evaluation	User satisfaction and usability as measured with questionniare "Usage of sound processor" consisting of rating scales on satisfaction of the sound processor	Baseline, 1 and 6 month(s)
Subjective evaluation SSQ	Subjective performance as measured by Speech, Spatial and Quality (SSQ) a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect"	Baseline, 1 and 6 month(s)

Collaborators and Investigators

• Sponsor: Oticon Medical
• Collaborators: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Måns Eeg Olofsson, MD, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2017
• Primary Completion (Actual): November 22, 2018
• Study Completion (Actual): November 22, 2018

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: C58

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No