Evaluation of New Custom Made Hearing Product Technology and Shell Modification (CPS)

Phonak

Status: Unknown

Conditions: Hearing Loss, Bilateral or Unilateral

Treatments: Device: hearing aid (MD class IIa) - ITE, BTE, RIC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545569

KEK-ZH-Nr. 2014-0459

Details and patient eligibility

About

The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.

Full description

This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa.

The purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. The results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Only adult participants between 18 and 99 years
• lnformed Consent as documented by signature (Appendix lnformed Consent Form)
• Ability to fill in a questionnaire conscientious
• Healthy outer ear (w/o previous surgical procedures)

Exclusion criteria

• Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product,
• Limited mobility and not in the position to attend weekly appointments
• Limited ability to describe listening impressions/experiences and the use of the hearing aid
• lnability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist
• Massively limited dexterity
• Psychological problems
• Central hearing problems

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Hearing Device Type A

Active Comparator group

Description:

In the ear (ITE) hearing aid, 1-3 weeks wearing

Treatment:

Device: hearing aid (MD class IIa) - ITE, BTE, RIC

Hearing Device Type B

Experimental group

Description:

In the ear (ITE) hearing aid, 1-3 weeks wearing

Treatment:

Device: hearing aid (MD class IIa) - ITE, BTE, RIC