ADHEAR Hearing System: Evaluation on experienced paediatric patients

• Research type

  Research Study

• Full title

  ADHEAR Hearing System: An evaluation on experienced paediatric hearing aid patients

• IRAS ID

  217184

• Contact name

  Ann Louise MacDermott

• Contact email

  ann-louise.mcdermott@nhs.net

• Sponsor organisation

  Birmingham Children's Hospital NHS Foundation Trust

• Duration of Study in the UK

  0 years, 1 months, 20 days

• Research summary

  This clinical study aims to evaluate the benefits of the ADHEAR Hearing aid system (ie. both the adhesive adapter in combination with a hearing aid (sound processor) worn as one unit. This is a hearing aid (sound processor) worn on an adhesive adapter placed behind the ear. The sound is then transmitted directly through the skin and bone to the cochlea (organ of hearing). The adhesive adapter will require changing on a twice weekly basis and the hearing aid and adhesive adapter are fully CE marked.
  This study is not funded by the manufacturer.
  The concept of this hearing aid system is to benefit children who do not have any external ear and those with ear canal problems including long standing ear disease. It is also an excellent cosmetic solution for those children who also have issues with self- esteem and are not complaint with their traditional hearing aids.
  primary aim
  1. Evaluate the objective hearing audiological outcomes from the ADHEAR hearing system This will be assessed objectively with standardised paediatric age appropriate hearing tests, both with and without the ADHEAR system being worn. as well as subjective assessment with child and carer validated outcome questionnaires.
  
  Secondary aims:
  1. Compare the audiological results with those of the previously worn Ponto hearing aid on a headband.
  2. Identify any effects of the adhesive plaster on the skin.
  3. Subjective outcomes for the ease of use of the ADHEAR hearing system using questionnaires

  These evaluations will be made on the day of fitting and re-evaluated 4-6 weeks later giving the child and carers time to become familiar with the hearing system and experience the ADHEAR system in all their usual environments.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  17/LO/0588

• Date of REC Opinion

  21 Apr 2017

• REC opinion

  Further Information Favourable Opinion