H90.4 H90.3
Conditions
Interventions
Group 1: monoaural supply with Vibrosonic alpha
Sponsors
Vibrosonic GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: IC1 Age 18-75 years IC2 Ability of subject to understand character and individual consequences of clinical trial IC3 Subject wears a hearing aid regularly for at least 3 months IC4 Written informed consent and privacy statement IC5 Eardrum accessibility IC6 Persistent, stable and pure sensorineural hearing loss 25 = PTA4 = 50 dB HL; hearing loss at 6 and 8 kHz = 75 dB HL IC7 True air-bone gap = 10 dB for frequencies {0,25; 0,5; 1; 1,5; 2; 3; 4; 6 kHz} with no more than two exceptions = 15 dB IC8 Normal tympanic membrane motility IC9 Stapedius reflex must be detectable for at least two frequencies for the ipsilateral measurement on the ipsilateral ear side IC10 All inclusion criteria and "patient-specific data” on the Vibrosonic alpha Candidacy Form were assessed and fulfil the inclusion criteria for Vibrosonic alpha as specified in the IFU (including the color indicating the depth of the ear canal, size of the ear canal module and length of the magnetic cable).
Exclusion criteria
Exclusion criteria: EC1 Anticipated non-availability for study visits / procedure EC2 Participation in other clinical trials or observation period of competing trials, respectively EC3 Held in an institution by legal or official order EC4 Pregnancy EC5 Insufficient command of German EC6 Tinnitus Grade II, III and IV (assessed with „Mini Tinnitus- Fragebogen“ nach Hiller & Goebel (2004); Value higher than 7;) EC7 Vestibular disease EC8 Endolymphatic hydrops and/or Meniére’s disease EC9 Ear pain EC10 Labyrinthitis EC11 Sudden or variable hearing loss EC12 Known otitis externa during the last 6 months EC13 Known cerumen obturans during the last 6 months EC14 Known abnormal middle ear anatomy EC15 Middle ear surgery EC16 Known retrocochlear hearing impairment or combined hearing impairment EC17 Allergies against Silicones, PEEK, Parylenes, Paraffines or Lidocain or any other material used in the investigational product or procedures EC18 Known chronical skin diseases that might influence the irritability of ear canal or tympanic membrane (e.g., neurodermitis, urticaria) EC19 Planned MRI examination during the study participation EC20 Planned diathermy treatment during the study participation EC21 Active medical implant(s), other than the investigational product EC22 Psychiatric or neurological brain disease EC23 Known chronic pain diseases that are under medical therapy EC24 Fine motor disorder EC25 Signs for ear canal or tympanic membrane pathology (e.g., tympanosclerosis, irritation of the ear canal) EC26 Abnormal cerumen production (no cerumen (dry ear) or ear canal blocked by cerumen over 80% of the diameter) EC27 Ear-canal and/or middle-ear disease including inflammation or effusion EC28 obsolete EC29 obsolete EC30 Vagal Reflexes (e.g., Cough attack, Impairment of consciousness) upon ICR manipulation EC31 Ear canal irritation due to ICR wearing period (grade > 1 for any symptom in Table 3. A mild erythema (grade 2) can be acceptable) EC32 ICR is not tolerated (Tolerability score = 3 assessed with Vibrosonic questionnaire) EC33 Less than 80% of the whole eardrum and / or less than 3.5 mm area around the umbo is visible on the scan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy EP: Exploratory evaluation of the acute improvement of speech recognition (Freiburger monosyllables audiometry at word recognition volume level L50), with vs without system inserted Primary safety EP: Absence of device related harm to hearing ability | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1) Exploratory investigation of the long-term tolerability of the Device. Target criterion: proportion of participants with wearing time >=28 days without untolerable adverse effects. Assessment by questionnaires and otoscopic examination of the ear canal. 2) Absence of serious infections of the ear canal (verification by otoscopy). 3) Exploratory examination of the stability of the coupling between the tympanic membrane and the hearing contact lens(R) by Békésy audiometry. Tertiary endpoints: additional audiological information and aspects of usability (questionnaires). | — |
Countries
Germany
Contacts
Public ContactFlorian Strobl
Vibrosonic GmbH
Outcome results
None listed