Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis: Pilot Study

NCT02456272 | Completed

• 2 other identifiers: RC31/14/73122014-A01764-43
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a French pilot study in the Toulouse University Hospital that will include a minimum of 30 patients with proven unilateral or asymmetric otosclerosis. Each one will receive a hearing aid for a minimum of 2 months and then undergo otosclerosis surgery.

Conditions

Otosclerosis

Keywords

Otosclerosis; Surgical treatment; Hearing aids

Outcome Measures

Primary Outcomes (1)

• Evolution of the quality of life (scored by GHSI)

  The primary outcome is to describe the evolution of the quality of life (scored by the Glasgow Health Status Inventory (GHSI)) during the hearing rehabilitation of otosclerosis frst with an external monaural hearing aid (support for at least 2 months), followed by a surgical treatment.

  4th Month

Secondary Outcomes (3)

• Evolution of the quality of life (scored by SSQ)

  Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery

• Evolution of the quality of life (scored by APHAB)

  Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery

• Evolution of the quality of life (scored by GBI)

  Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery

Study Arms (1)

External hearing aid & Otosclerosis surgery

EXPERIMENTAL

Trying an hearing aid for at least two months and then undergo otosclerosis surgery

Device: External hearing aid; Procedure: Otosclerosis surgery

Interventions

External hearing aid DEVICE

The external hearing aid (monaural) with an auditory prosthesis contour type, brand PHONAK type Bolero Q70 will be provided to the patients during a minimum of 2 months.For reasons of standardization and comparability of results, only one type of prosthesis (medium-high range) will be provided. The settings will be performed by audiologists of ENT service during the inclusion visit.

External hearing aid & Otosclerosis surgery

Otosclerosis surgery PROCEDURE

Surgical restoration of the columellar effect consists of the intraoperative verification of the stapedo-vestibular ankylosis which provides diagnostic. Then a stapedotomy (laser or Ototool°) is performed and partial ossicular prosthesis s inserted between stapedotomy and the long process of the incus.

External hearing aid & Otosclerosis surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nosological criteria:
• Unilateral or bilateral asymmetric otosclerosis
• Conductive hearing loss of at least 30 dB with an average loss Rinne means greater than or equal to 20 dB (on frequencies 0.5, 1, 2, 4 kHz)
• Normal tympanum
• Temporal bones CT-scan showing radiologic signs of otosclerosis
• Related to treatment criteria:
• No previous treatment for the otosclerosis

You may not qualify if:

• Disease's related criteria:
• Far advanced otosclerosis defined as less than 95dB air conduction at all frequencies or lower bone conduction 55dB on at least one frequency
• Cochlear otosclerosis objectified on the temporal bones Ct-scan
• Others clinical or radiological diagnostics: cholesteatoma, tympanic membrane perforation, geyser's syndrome, ossicular dislocation, ossicular malformation, tympanosclerosis.
• Associated pathologies: tympanic retraction, effects of chronic otitis, tubal dysfunction.
• Criteria about proposed treatments:
• Anesthesia contraindications
• Operative contraindication: clotting disorders, tympanum retraction and tubal dysfunction, geyser's syndrome, single ear, patient refusal.
• Criteria relative to study's explorations: Language barrier (questionnaires, tests), cognitive disorders.
• Criteria relating to previous treatment: Previous hearing aid or surgery Administrative criteria: Patients minors, incapable adults, adults under guardianship, incapable of giving consent.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse University Hospital (CHU de Toulouse)

Toulouse, 31059, France

Location

Related Publications (1)

• Molinier CE, Gallois Y, Deguine O, Iversenc G, Vales O, Taoui S, Lepage B, Fraysse B, Marx M. Stapedotomy Versus Hearing Aids in the Management of Conductive Hearing Loss Caused by Otosclerosis: A Prospective Comparative Study. Otol Neurotol. 2022 Aug 1;43(7):773-780. doi: 10.1097/MAO.0000000000003585.

  PMID: 35878633 RESULT

MeSH Terms

Conditions

Otosclerosis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Mathieu MARX, MD

  Toulouse University Hospital (CHU Toulouse)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 28, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 10, 2025

Record last verified: 2018-05

Locations

FR (1)