OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia

Обзор

The aim of this study is to compare speech perception in noise with one activated Osia (unilateral) versus two activated Osia (bilateral), in children with high grade microtia/ear atresia fitted with bilateral Osia implants. In order to do these measurements, the enrolled children will get OSIA implants on both sides during a standard surgery procedure. Six months following the implantation, audiologist testing will be done with one implant active compared to both.

Подробное описание

High grade microtia corresponds to a congenital malformation of the pinna and the external auditory meatus associated with a malformation of the middle ear. Ear atresia a congenital malformation of the external auditory meatus and middle ear, associated to a normal or near norma pinna.

In the case of hearing loss related to high grade microtia or ear atresia, be the type of hearing rehabilitation cannot be achieved with conventional air-conduction hearing aids, due to the absence of an ear canal. Different options are available and reimbursed by French medical insurance system. The Cochlear Osia implant is a semi-implantable bone conduction hearing aids. It is an active, transcutaneous (closed-skin) implant, which has the CE mark and is covered by the Health Insurance Fund for adults.

When deafness is bilateral and unaided, it impacts the development of oral language, daily life, and academic progress. Studies also show that speech perception in noisy environments is impaired. This can be very disabling, especially for young school-aged children. There are also studies showing that sound localization is improved when using two hearing aids.

Although bilateral fitting has benefits, bone conduction hearing aids are not always surgically placed bilaterally in children with ear aplasia and no clinical research has yet been conducted with the OSIA system. The objective of this study is to evaluate the effectiveness of bilateral implantation of the Osia System in children with high grade microtia or ear atresia.

Once the implantation surgery is done, the patient will come back for at least three visits: two adjustment visits, 1 month and 5 months afterwards, and two ENT consultations at 1 month and 6 months. These visits are part of the usual follow-up for children with bone conduction implants. Experimental audiological measurements will be carried out at the 6-month visit.

Вмешательства

• Другое Audiological tests
  FraSIMAT (French Simplified Matrix Test) and ERKI tests will be performed with one activated implant versus both activated 6 months after surgery
• Поведенческое Speech, Spatial and Qualities of Hearing Scale
  The patients will answer the SSQ (Speech, Spatial and Qualities of Hearing Scale) 6 months after his surgery.

Первичные конечные точки

• Implantation success [Срок оценки: 6 months]

Вторичные конечные точки (7)

• Prosthetic gain [Срок оценки: 5 months]
• Prosthetic gain [Срок оценки: 6 months]
• Prosthetic gain [Срок оценки: 6 months]
• Security and skin tolerance [Срок оценки: 6 months]
• Sound localization [Срок оценки: 6 months]
• Hearing quality [Срок оценки: 6 months]
• Daily use [Срок оценки: 6 months]

Критерии участия

Критерии включения

• To be aged between 7 and 17 years old at the time of enrolment
• Use spoken French as primary mode of communication
• Diagnostic of moderate to severe bilateral high grade microtia and/or ear atresia resulting in conductive hearing loss with an ACPTA between 60 and 80 dB and a BCPTA between 0 and 20 dB
• Fitted with a unilateral or bilateral headband/headband/adhesive bone conduction device for more than 12 months.
• In case of microtia: after or before ear reconstruction planned using the conventional costal cartilage graft procedure; anatomical conditions allowing implantation of the OSIA outside the area of a future ear reconstruction.
• To be a medical and audiological candidate for the OSIA system
• To be affiliated with a health insurance plan or be eligible for it
• Signed consent from the legal guardian(s)

Критерии исключения

• Weight less than 7 kg (CE marking limit)
• Diagnosed with a severe neurological condition, identified by an MRI and/or a neuropediatric assessment
• Diagnosed with a severe cognitive impairment, child psychiatric impairment, or developmental delay
• Diagnosed with a severe cochleovestibular or cochlear nerve malformation
• Live in a social context that does not allow for long-term follow-up
• To be part of a family that does not understand spoken French
• Already equipped with one (or two) bone conduction implant(s)
• Affiliated with minimum state healthcare (AME)
• To currently be pregnant or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hôpital Necker Enfants Malades — Paris

Публикации

• Snik AF, Mylanus EA, Proops DW, Wolfaardt JF, Hodgetts WE, Somers T, Niparko JK, Wazen JJ, Sterkers O, Cremers CW, Tjellstrom A. Consensus statements on the BAHA system: where do we stand at present? Ann Otol Rhinol Laryngol Suppl. 2005 Dec;195:2-12. doi: 10.1177/0003489405114s1201. PMID 16619473
• Goycoolea M, Ribalta G, Tocornal F, Levy R, Alarcon P, Bryman M, Cagnacci B, Catenacci C, Oyanguren V, Vilches I, Briones V, Garcia R. Clinical performance of the Osia system, a new active osseointegrated implant system. Results from a prospective clinical investigation. Acta Otolaryngol. 2020 Mar;140(3):212-219. doi: 10.1080/00016489.2019.1691744. Epub 2020 Feb 18. PMID 32068449
• Mylanus EAM, Hua H, Wigren S, Arndt S, Skarzynski PH, Telian SA, Briggs RJS. Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System. Otol Neurotol. 2020 Oct;41(9):1249-1257. doi: 10.1097/MAO.0000000000002794. PMID 32925852
• Pla-Gil I, Redo MA, Perez-Carbonell T, Martinez-Beneyto P, Alborch MO, Ventura AM, Monteagudo EL, Ribas IP, Algarra JM. Clinical Performance Assessment of a New Active Osseointegrated Implant System in Mixed Hearing Loss: Results From a Prospective Clinical Investigation. Otol Neurotol. 2021 Aug 1;42(7):e905-e910. doi: 10.1097/MAO.0000000000003116. PMID 33710155
• Rauch AK, Wesarg T, Aschendorff A, Speck I, Arndt S. Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia(R). Eur Arch Otorhinolaryngol. 2022 Sep;279(9):4279-4288. doi: 10.1007/s00405-021-07167-9. Epub 2021 Nov 18. PMID 34792628
• Cushing SL, Gordon KA, Purcell PL, Feness M, Negandhi J, Papsin BC. Surgical Considerations for an Osseointegrated Steady State Implant (OSIA2(R)) in Children. Laryngoscope. 2022 May;132(5):1088-1092. doi: 10.1002/lary.29892. Epub 2021 Oct 23. No abstract available. PMID 34687460
• Stenfelt S, Zeitooni M. Binaural hearing ability with mastoid applied bilateral bone conduction stimulation in normal hearing subjects. J Acoust Soc Am. 2013 Jul;134(1):481-93. doi: 10.1121/1.4807637. PMID 23862823
• Stenfelt S. Transcranial attenuation of bone-conducted sound when stimulation is at the mastoid and at the bone conduction hearing aid position. Otol Neurotol. 2012 Feb;33(2):105-14. doi: 10.1097/MAO.0b013e31823e28ab. PMID 22193619

Идентификаторы

NCT: NCT07358728 · APHP250940 · IDRCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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