Examining the Impact of Physician Influence on Hearing Aid User Satisfaction and Retention

NCT02842905 | Completed

• 1 other identifier: H15-01282
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

Most of us will experience some degree of hearing loss as we get older. It can affect one or both ears and without treatment causes difficulty with following conversations in the home or workplace. Audiologists are trained to diagnose and treat hearing loss and tinnitus problems. They also dispense, and fit hearing aids. Physicians do not provide or fit hearing aids directly, however they diagnose hearing loss and can recommend hearing aids amongst other treatments for hearing loss. It is undecided whether consulting with a physician in addition to an audiologist will improve user's satisfaction with hearing aids, compared to consulting with an audiologist alone. The purpose of this study is to determine whether physician involvement (in addition to an audiologist) in the hearing aid fitting process improves users' satisfaction with hearing aids. The study utilizes questionnaires to assess satisfaction with hearing aids. Furthermore, participants decision to keep the purchased hearing aids will be recorded. The study will take place in the clinics of family doctors, Otolaryngology (Ear) surgeons and audiologists. A hearing aid suitable for the needs of the participant will be fitted by an audiologist. In the first 21days after the fitting, participants will attend follow-up visits with the audiologists for adjustments to the hearing aids to best meet their specific listening needs. After 21 days, eligible participants will be allocated to either the Control or Test groups. Participants in both groups will be asked to describe the change in their hearing performance related to the use of hearing aids to their audiologist(Control) or Physician (Test) at a follow-up visit. At the study's final visit, participants will be asked to complete a satisfaction-based questionnaire. The time taken to fit a hearing aid varies depending on the individual needs of the patient. It is estimated that at most 10 visits will be required over 90 days to complete the hearing aid fitting and study processes. These visits will be of 30 minutes duration on average, except for the initial and final visits which lasts for 45 minutes. A patient will spend a maximum of 330 minutes to complete the hearing aid fitting process, but only 25 minutes of this time will be specifically related to the study. The study is intended to determine the satisfaction with hearing aids and consultations with health professionals.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Satisfaction with Amplification in Daily Life questionnaire score

  Participant determined satisfaction level with the hearing aid based on the Satisfaction with Amplification in Daily Life (SADL) questionnaire score.

  SADL questionnaire completed at patient's final visit or when hearing aid is returned (77-90 days from initial hearing aid fitting)

Secondary Outcomes (1)

• Proportion of Hearing aid returned

  77-90 day post fitting

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Fitting Audiologist completion of the Client Outcome Scale of Improvement at a post fitting follow up visit.

Other: Fitting Audiologist completion

Test Group

EXPERIMENTAL

Participant's physician completion of the Client Outcome Scale of Improvement at a post fitting follow up visit.

Other: Participant's Physician completion

Interventions

Fitting Audiologist completion OTHER

Phase II of the COSI (Client Oriented Scale of Improvement) questionnaire completed in a scheduled visit with the fitting Audiologist

Control Group

Participant's Physician completion OTHER

Phase II of the COSI (Client Oriented Scale of Improvement) questionnaire completed in a scheduled visit with the Participant's Physician

Test Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Sensorineural hearing loss greater than 25 dB averaged over frequencies 0.5, 1, 2 and 4 KHz; or 2, 3 and 4 KHz on pure tone audiometry in either ear.
• Have used a hearing for up to 21 days after being fitted

You may not qualify if:

• Age under 55 years
• Unable to follow doctor/audiologist's instructions
• Previous hearing aid use

Sponsors & Collaborators

• University of British Columbia: lead
• NexGen Hearing Inc.: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

Related Publications (1)

• Zhao K, Hambley M, Venema T, Marynewich S, McNeely B, Nunez DA. Effect of Physician Consultation on Satisfaction With Hearing Aid Use: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Jul 1;148(7):630-635. doi: 10.1001/jamaoto.2022.0927.

  PMID: 35588353 DERIVED

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Desmond Nunez, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 25, 2016
• Study Start: July 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: From July 2019- June 2020
• Access Criteria: By contacting corresponding author in peer reviewed publication.

Locations

CA (1)