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Completed

NCT Number: NCT03374787

Evaluation of 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.

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Key information

Conditions

Conductive Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural Mixed Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ENT departement, Sahlgrenska University Hospital

Gothenburg, 413 46, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fusion Sound Processor

Device

Sound Processor

Primary outcomes

  1. Aided Thresholds Fusion-unaided PTA

    Time frame: 6 months

    Difference between Fusion-aided and unaided sound field Pure Tone Average of thresholds of frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)

Secondary outcomes

  1. Aided Thresholds Fusion-unaided

    Time frame: 6 months

    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

  2. Aided Thresholds Fusion PTA4

    Time frame: Baseline, 1 and 6 month(s)

    Difference between Fusion-aided sound field PTA4, the average for frequencies 500, 1000, 2000 and 4000 Hz (PTA 4)

  3. Aided Thresholds Fusion

    Time frame: Baseline, 1 and 6 month(s)

    Difference between Fusion-aided sound field pure tones at frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz at

  4. Aided Thresholds Fusion-BCI PTA4

    Time frame: 6 months

    Difference between Fusion-aided and BCI-aided sound field Pure Tone Average 4 at frequencies 500, 1000, 2000 and 4000 Hz (PTA4)

  5. Aided Thresholds Fusion-BCI

    Time frame: 6 months

    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. Speech Intelligibility Fusion-unaided %

    Time frame: 6 months

    Difference between Fusion-aided and unaided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used.

  7. Speech Intelligibility Fusion-unaided Signal to Noise Ratio (SNR)

    Time frame: 6 months

    Difference between Fusion-aided and unaided sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.

  8. Speech Intelligibility Fusion %

    Time frame: Baseline, 1 and 6 month(s)

    Difference between Fusion-aided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used.

  9. Speech Intelligibility Fusion SNR

    Time frame: Baseline, 1 and 6 month(s)

    Difference between Fusion-aided sound field sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.

  10. Speech Intelligibility Fusion-BCI %

    Time frame: 6 months

    Difference between Fusion-aided BCI-aided speech intelligibility scores (in % correct). Score indicates number of word repeated correctly with aided with the Fusion sound processor compared to unaided. Ranges from 0-100, a higher score indicates better performance. No scale is used

  11. Speech Intelligibility Fusion-BCI SNR

    Time frame: 6 months

    Difference between Fusion-aided and BCI-aided sound field speech intelligibility scores in SNR. Score indicates the signal to noise ratio where the subject can repeat 50% of the words correct. A lower score means a better outcome. No scale is used.

  12. Magnet Strength

    Time frame: Baseline, 1 and 6 month(s)

    Difference in magnet strength measured on the patient's heads in Newton

  13. IPS (Inflammation, Pain, Skin Height/Numbness) Evaluation

    Time frame: Baseline, 1 and 6 month(s)

    Combined score of IInflammation, Pain and Skin height/numbness scale 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). Lower score means better performance

  14. Subjective Evaluation

    Time frame: Baseline, 1 and 6 month(s)

    User satisfaction and usability as measured with questionniare "Usage of sound processor" consisting of rating scales on satisfaction of the sound processor. The scale used is a scale with descriptive values.

  15. Subjective Evaluation SSQ

    Time frame: Baseline, 1 and 6 month(s)

    Subjective performance as measured by Speech, Spatial and Qualities of hearing (SSQ) a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". A higher score means better performance.

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Collaborators

  • Sahlgrenska University Hospital

Registry information

Official study title

Single Center Evaluation of a Sound Processor for a Transcutaneous System

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2017
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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