This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective study conducted at eight European hospitals, aiming to treat 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing system (BAHS). The primary objective of the study is to demonstrate that the Sentio system improves the hearing on the implanted ear, compared with the unaided situation.
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective, multicentre study sponsored by Oticon Medical AB, which will be conducted at eight hospitals across Europe (UK, Spain and the Netherlands). A total of 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing system (BAHS) will be included. Participation is voluntary and the decision to participate must be well-founded and well informed. The Sentio system is a transcutaneous bone conduction hearing system (an implant and an external sound processor) for individuals with certain types of hearing losses. The implant is implanted into the bone behind the ear (mastoid and temporal bone area). After a period of skin healing, a sound processor which transmits sound waves to the implant can be magnetically attached. The implant transforms the sound waves to vibrations, which are then transmitted to the inner ear via the bone. The primary objective of the study is to demonstrate that the Sentio system improves the hearing on the implanted ear, compared with the unaided situation. The study includes eight study visits; one before surgery, the surgery visit, and six follow-up visits, with the last visit taking place 12 months after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The Sentio system consists of the Sentio 1 Mini sound processor (SP) and Sentio Ti implant with fixation band and screws.
University Medical Center Groningen
Groningen, Netherlands
RECRUITINGRadboud University Medical Center
Nijmegen, Netherlands
RECRUITINGHospital Universitario de Donostia
San Sebastián, Spain
RECRUITINGHospital Universitario Virgen Macarena
Seville, Spain
RECRUITINGHospital Universitario y Politécnico La Fe
Valencia, Spain
RECRUITINGBirmingham Children's hospital, Birmingham Women's and Children's NHS Foundation Trust
Birmingham, United Kingdom
RECRUITINGThe Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
RECRUITINGGreat Ormond Street Hospital, Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom
RECRUITINGDemonstrate that the Sentio system improves hearing on the implanted ear.
Functional gain with the Sentio system, i.e. the difference between pre-operative unaided and post-operative aided sound field thresholds on the implanted ear. The functional gain is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Time frame: 3 months post-surgery
Evaluation of the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.
Tabulated adverse events and serious adverse events related to the device reported from surgery throughout the investigation reported at 3 months post-surgery.
Time frame: 3 months post-surgery
Functional gain
Functional gain is used to assess the performance of the Sentio system. The functional gain is a calculation and is defined as the difference between unaided and aided sound field thresholds. The average functional gain is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Time frame: 12 months post-surgery
Effective gain
Effective gain is used to assess the degree the Sentio system compensates for the hearing loss on the implanted ear in patients with mixed/conductive hearing losses. Effective gain is a calculation and is defined as the aided threshold relative to the BC (unmasked bone conduction) threshold and is calculated as the difference in dB between aided sound field thresholds and BC in situ hearing thresholds. The average effective gain (PTA4) is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz.
Time frame: 12 months post-surgery
Assessment of speech recognition improvement
Difference in speech recognition score (%) between pre-operative unaided condition and Sentio-aided condition, measured in quiet on the implanted ear.
Time frame: 3 months post-surgery
Assessment of listening-related fatigue
Change in Vanderbilt Fatigue Scale (VFS) questionnaire score between pre-operative unaided condition at baseline and aided condition post-surgery. The Vandebilt Fatigue Score questionnaire as a valid measure of listening-related fatigue in children.
Time frame: 6 months post-surgery
Assessment of quality of life
Glasgow Children Benefit Inventory (GCBI) questionnaire score addressing the consequences of a specific intervention on various aspects of the child's day-to-day life. The score goes from -100 (max negative effect) to +100 (max positive effect).
Time frame: 12 months post-surgery
Usage hours
Sound processor usage hours per day.
Time frame: 12 months post-surgery
Duration of surgery
Average length of surgery measured in minutes.
Time frame: 3 months post-surgery
IPS (Inflammation, Pain, Skin numbness) scores
Distribution of IPS scores (Inflammation score 0-4; Pain score 0-2; Skin numbness score 0-2) assigned by investigator. The IPS score is presented as \[Ix Px Sx\] with x being the individual score for each parameter. A higher score corresponds to a poorer outcome.
Time frame: 12 months post-surgery
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