acoustic neuroma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Chinese population over 18 years old and under 80 years old (including 18 and 80 years old) 2) Can understand and repeat Mandarin Chinese as judged by the principal investigator 3) The subjects signed the informed consent form with good compliance 4) Patients with postoperative acoustic neuroma, AAO-HNS hearing assessment grade C or D 5) Two consecutive teeth on at least one side of the maxillary posterior alveolar (implants are acceptable, but dentures are not acceptable)
Exclusion criteria
Exclusion criteria: 1) Currently using other bone conduction hearing aids, such as Baha Attract, Bone bridge, etc. 2) Those who are allergic to epoxy resin polymers 3) Known to have a life-threatening disease, or have a contraindication to the chosen dental or medical procedure 4) Known medical conditions that may interfere with the efficacy of the medical treatment, such as inability to breathe through the nasal passages (severe perennial allergic rhinitis, chronic sinusitis with nasal polyps) 5) The teeth are known to have the following abnormalities: a. Wearing a temporary crown or undergoing dental treatment; b. No continuously available molars; c. Currently undergoing orthodontic treatment; d. There are one or more caries that have not been treated in the range of the target teeth where the device is worn; e. Suffering from moderate to severe periodontitis around the target tooth where the device is worn; f. Suspected oral or facial injury or swelling of any type; g. Severe pain to palpation in any area of the mouth, face or neck; h. Moderate to severe heat sensitivity of the teeth on the upper side of the mouth; i. The subject is currently undergoing temporomandibular joint treatment, pain, full mouth reconstruction or posterior dental implants 6) Known psychological or psychiatric problems that may interfere with compliance, understanding, knowledge, and ability to cooperate 7) Those who have received less than 6 years of education and have speech comprehension impairments 8) The investigator believes that it may hinder the evaluation of the results or pose a health risk to the subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall effectiveness of the subjects wearing the test device; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pure tone air conduction hearing threshold change value;sound source localization ability;percentage of subjects with significantly improved hearing aid effect;device performance of the test device; | — |
Countries
China
Contacts
SunYat-Sen Memorial Hospital of Sun Yat-Sen University