Audiological results of the middle ear implantation in patients with mixed hearing loss after the middle ear surgery: prospective multicenter study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003143

Enrollment

Registered

2018-08-29

Start date

2018-10-07

Completion date

Unknown

Last updated

2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Under general anesthesia, postauricular incision is made. After opening of facial recess and making the bony well, middle ear implantation is done using Vibrant Soundbridge® system.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? An adult patient aged 20-80 years who underwent mastoidectomy and tympanoplasty with chronic otitis media (including chronic otitis media with cholesteatoma) ? Patient with bone conduction hearing threshold of 25dB or higher and mean air-bone gap of 25dB or higher in mixed hearing loss ear, air conduction threshold of 45dB or higher in other side ? Patient with PBmax over 50% in speech audiometry ? Difficult to expect hearing improvement with ossiculoplasty ? Patient who do not get enough gain in wearing a general hearing aid or difficult to wear a hearing aid because of otorrhea or change in the shape of the external auditory canal ? No contraindication to general anesthesia ? Patient who agrees to participate in the clinical study and have signed a written consent form him/herself

Exclusion criteria

Exclusion criteria: ? Those who are illiterate or unable to read the written consent of a foreigner or have difficulty understanding the clinical trial due to mental retardation ? Patients who do not have residual hearing or whose speech discrimination score is less than 50% are not expected to have hearing improvement even after middle ear implantation ? Patients who do not have residual hearing and who are indication for cochlear implants ? Patients who are expeected to impreve hearing even by using hearing aids ? Patients with suspected anomalies of inner ear and cochlear nerve pathway and requiring other method of treatment ? Patients judged to be inappropriate for this clinical trial by the judgement of the investigator

Design outcomes

Primary

Measure	Time frame
APHAB(Abbreviated Profile of Hearing Aid Benefit), K-IOI-HA(Korean version of International Outcome Inventory for Hearing Aids) questionnaire	—

Secondary

Measure	Time frame
Pure tone audiometry;Speech audiometry	—

Countries

Korea, Republic of

Contacts

Public ContactYehree Kim

Asan Medical Center

yehreek@hotmail.com+82-2-3010-3710

Outcome results