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Completed

NCT Number: NCT04271761

Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients

This investigation is a single-centre, prospective, single-arm, post-market, non-interventional, pilot clinical investigation designed to characterize microphone sensitivity and maximum stable gain of the Cochlear Carina System.

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Key information

Conditions

Hearing Impairment Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CUF Porto Hospital

Porto, 4100-180, Portugal

About this study

The totally implanted Carina System is an active middle ear implant where all components are implanted under the skin. Placing a microphone under the skin affects its acoustic sensitivity and vibration sensitivity. Software is now available to enable non-intrusive microphone measurements in existing patients with the Carina device, through a wireless link to the implant. Detailed knowledge of the acoustic sensitivity of the implanted microphone and objectively measured maximum stable gain, and its inter-individual variability, will allow more accurate calculation of overall system performance, and thereby more accurate prediction of clinical outcomes.

Subjects will attend one scheduled study visit to be assessed; several objective acoustic measurements will be performed that do not require active participation from the subject. No data monitoring committee will be used for this clinical investigation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eighteen years of age or older at the time of enrolment in the study
  • Current recipient of a Cochlear Carina System.

Exclusion criteria

  • Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator.

Treatment and study plan

Non-interventional, post-market, pilot study of Carina Cochlear System

Other

Several objective acoustic measurements will be performed that do not require active participation from the subject.

Primary outcomes

  1. Acoustic Sensitivity of Implanted Carina Microphone

    Time frame: from date of enrolment through to study visit, an average of 1 month

    The acoustic sensitivity of the implanted microphone was measured using a white noise acoustic test signal was presented from a loudspeaker, with the sound pressure level monitored with an external probe microphone positioned over the location of the implanted microphone and the signal level at the implanted microphone recorded through a wireless link to the Carina implant.

  2. Ratio of Response of Carina Microphone : Accelerometer for Acoustic Stimulation

    Time frame: from date of enrolment through to study visit, an average of 1 month

    Ratio [dB] of response of implanted microphone to response of implanted accelerometer, in-situ, for audiometric frequencies 250-6000 Hz, median and percentiles

  3. Carina Maximum Stable Gain

    Time frame: from date of enrolment through to study visit, an average of 1 month

    Transfer function from Carina output to actuator [dB FS] to Carina input from implanted microphone [dB FS], for audiometric frequencies 250-6000 Hz, with ear canal open and ear canal plugged.

  4. Carina Microphone Impulse Response for Acoustic and Actuator Stimulation

    Time frame: from date of enrolment through to study visit, an average of 1 month

    Identification of the system's acoustic and vibration transfer functions including non-linear components.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

A Prospective, Single-centre Evaluation of Carina Microphone Sensitivity and Maximum Stable Gain in Adult Recipients

Acronym: CAMSEN

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2020
Registry last updated
Jul 16, 2021

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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