Primary Objective: The present study is designed to answer the question whether the surgically altered OEAC leads to a perceived change in sound quality.Secondary Objective(s): To determine the differences in RECD and REUR induced by different OEAC…
ID
Source
Brief title
Condition
- External ear disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the subjective preference for the sound quality,
measured by paired comparison category rating and a VAS.
Secondary outcome
-
Background summary
In individual cases, patients have reported a subjective improvement of sound
quality after surgical alteration of the osseous external auditory canal
(OEAC). To our knowledge, there are no studies on the effect of a change in the
external ear acoustic properties on perceived sound quality. The present study
aims to investigate the subjective sound quality of a surgically changed OEAC
by using sound simulations of surgically altered ears and present these
conditions to two both the hearing impaired subjects and normal hearing
listeners.
Study objective
Primary Objective:
The present study is designed to answer the question whether the surgically
altered OEAC leads to a perceived change in sound quality.
Secondary Objective(s):
To determine the differences in RECD and REUR induced by different OEAC surgery
procedures such as mastoïdectomy, obliteration of an open cavity, exostose,
etcetera.
Study design
This study is an observational study including subjects with surgically altered
OEAC, and a panel of normal hearing listeners. The different outer ear canal
acoustics are simulated using filtering based on both the REUR and the RECD of
the surgically altered OEACs of the hearing impaired subjects. These
simulations of the different OEAC conditions facilitate a perceptive evaluation
in both the hearing impaired subjects using the RECD and an insert earphone,
and in the normal hearing listeners using the REUR in a free field setting.
During one visit, ranging from 0.5 to 2 hours, the hearing capacity and
external ear acoustic properties are characterized using standard clinical
tests (i.e. pure tone audiometry, the in situ measurement of the REUR and RECD,
and tympanometry). In addition, a subjective comparison category rating is
included to determine the individual preferences in sound quality in terms of
naturalness, sharpness, and etcetera. A VAS score is used to determine the
subjective overall sound quality.
Study burden and risks
Since this study is observational, the burden for the patients is minimal.
Several tests similar or equal to those done in standard clinical practice will
be done during one visit. The primary outcome of the study aims to provide more
information about the effects of OEAC surgery on the subjective perception of
sound. This is relevant for patients who need to undergo an otological
operation in which the OEAC acoustics will be altered, in addition to the
medical considerations.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Aged 18 years or older.
- Sufficient knowledge of the Dutch language, both spoken and written, in order to being able to participate in the perceptual evaluation experiment.
- Hearing impaired subjects:
o Uni- or bilateral surgically altered OEAC
o pure tone hearing thresholds of 70 dB(HL) or better for all audiometric frequencies between 250 and 8000 Hz in the ear(s) with the altered OEAC.
- Normal hearing listeners:
o Pure tone hearing thresholds of 20 dB(HL) or better for all audiometric frequencies between 250 and 8000 Hz.
o no history of ear infection nor any ear surgery.
Exclusion criteria
- Pure tone hearing thresholds do not meet the specified criteria.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48271.018.14 |